LIST OF DRUGS PROHIBITED FOR MANUFACTURE AND SALE THROUGH GAZETTE NOTIFICATIONS UNDER SECTION 26A OF DRUGS & COSMETICS ACT 1940 BY THE MINISTRY OF HEA

DRUGS PROHIBITED FROM THE DATE OF NOTIFICATION

1. Amidopyrine

2. Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.

3. Fixed dose combinations of Atropine in Analgesics and Antipyretics.

4. Fixed dose combinations of Strychnine and Caffeine in tonics.

5.Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.

6. Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.

7. Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.

8. Phenacetin.

9. Fixed dose combinations of antihistaminic with anti-diarrhoeals.

10. Fixed dose combinations of Penicillin with Sulphonamides.

11. Fixed dose combinations of Vitamins with Analgesics.

B12.Fixed dose combinations of any other Tetracycline with Vitamin C.

E13.Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.

ccc14. Fixed dose combinations of Corticosteroids with any other drug for internal use.

ccc15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.

16.Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches.

17.Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).

18. Penicillin skin/eye Ointment.

19. Tetracycline Liquid Oral preparations.

20. Nialamide.

21. Practolol.

22. Methapyrilene, its salts.

c 23. Methaqualone.

& 24. Oxytetracycline Liquid Oral preparations.

& 25. Demeclocycline Liquid Oral preparations.

T 26. Combination of anabolic Steroids with other drugs.

cc 27.Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. (Subs. By Noti. No. 743 (E) dt 10-08-1989)

* 28.Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.

J*29.Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide, except those which provide daily adult dose given below:

Drugs Minimum Maximum

Rifampicin 450 mg 600 mg

Isoniazid 300 mg 400 mg

Pyrazinamide 1000mg 1500 mg

* 30. Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.

* 31.The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.

* 32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v
whichever is appropriate.

** 33.Fixed dose combination of Ethambutol with INH other than the following: INH
Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.

** 34. Fixed dose combination containing more than one antihistamine.

B**35.Fixed dose combination of any anthelmintic with cathartic/purgative except for
piperazine/Santonim.

**36. Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.

** 37.Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.

G** 38.Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol

** 39.Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.

** 40.Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.

** 41.Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof.

** 42.Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not systemically absorbed.

*** 43. Chloral Hydrate as a drug.

b 44. Dovers Powder I.P.

b 45. Dover’s Powder Tablets I.P.

A 46.Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.

A 47.Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.

A 48.Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.

A 49.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Lorloperamide or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.

A 50.Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.

A 51. Fixed dose combination of antidiarrhoeals with electrolytes.

C 52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:
(a) Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:- Sodium - 50 to 90 millimoles. Total osmolarity - 240 - 290 milli osmoles. Dextrose : Sodium molar ratio - Not less than 1:1 and not more than 3:1
(b) Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain :- Total osmolarity - Not more than 2900 milli osmoles. Precooked rice- Equivalent to not less than 50 gm and not more than 80 gm as total replacement of Dextrose.
(c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labeled with the indication for "Adult Choleratic Diarrhoea" only.
(d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharin sweetening agent.

D 53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.

H.D54. Fixed dose combination of Analgin with any other drug.

D 55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).

D 56. Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.

F 57. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.

F 58. Fenfluramine and Dexfenfluramine.

I 59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride .

K 60. Rimonabant.

LIST OF GAZETTE NOTIFICATION PUBLISHED

The Principal Notification GSR 578 (E) dt.23.7.83.

c Added b GSR 4(E) dated 31.01.1984

& Added b GSR 322(E) dated 03.05.1984\

T Amended by GSR 863(E) dated 22.11.1985

cc Amended by GSR 743(E) dated 10.08.1989

ccc Amended by GSR 1057(E) dated 03.11.1988

* Added by GSR 999(E) dated 26.12.1990

* Added by GSR 69(E) dated 11.02.1991

xxx Added by GSR 304(E) dated 7.06.1990

@ Added by GSR 444(E) dated 7.06.1992

b Added by GSR 111(E) dated 22.02.1994

A Added by GSR 731(E) dated 30.09.1994

B Added by GSR 848(E) dated 7.12.1994

C Added by GSR 57(E) dated 7.02.1995

D Added by GSR 633(E) dated 13.09.1995

E Added by GSR 793(E) dated 13.03.1995

Added by GSR 93(E) dated 25.05.1997

F Added by GSR 499(E) dated 14.08.1998

G Added by GSR 394(E) dated 19.05.1999

H Added by GSR 405(E) dated 3.06.1999

I Added by GSR 169(E) dated 12.03.2001

J Added by GSR 290(E) dated 16.04.2008

K Added by GSR 885(E) dated 11.12.2009

List of Drugs Prohibited for Import

1. Nialamide

2. Practolol

3. Amiopyrine

4. Phenacetin

5. Methapyrilene and its salts

a 6. Methaqualone

b 7. Chloral Hydrate as a drug

c 8. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization and contraceptive.

9. Fenfluramine and Dexfenfluramine

d 10. Rimonabant

List of Gazette Notification Pblished

a Added by GSR 48(E) dated 31.1.1984

b Added by GSR 303(E) dated 7.6.1991

c Added by GSR 498(E) dated 14.8.1998

d Added by GSR 884(E) dated 11.12.2009

DRUGS PROHIBITED FOR MANUFACTURE , SALE AND DISTRIBUTION FROM SUBSEQUENT DATE

Drugs Formulation Effective date Notification

1.Cosmetics Licensed as toothpaste/tooth With immediate GSR 444(E)

powder containing tobacco. effect dt.30.4.92

2.Parenteal Preparations fixed dose Jan 1,1998 GSR 93(E)

combination of streptomycin with dt.25.2.97

Pencillin

3.Fixed dose combination of Vitamin B1, Jan 1,2001 GSR 702(E)

Vitamin B6 and Vitamin B12 for dt.14.10.99

human use

4.Fixed dose combination of haemoglobin Sep 1,2000 GSR 814(E)

in any form (natural or synthetic). dt.16.12.99

5.Fixed dose combination of Pancreatin or Sept. 1,2000 GSR 814(E)

Pancrelipase containing amylase, protease dt.16.12.99

and lipase with any other enzyme.

6. Fixed dose combination of Nitrofurantoin Jan 1,2002 GSR 170(E)

and trimethoprim. dt.12.3.01

7.Fixed dose combination of Phenobarbitone Jan 1,2002 GRS 170(E)

with any anti-asthmatic drugs. dt.12.3.01

8.Fixed dose combination of Phenobarbitone Jan 1,2002 GSR 170(E)

with Hyoscin and/or Hyoscyamine dt.12.3.01

9.Fixed dose combination of Phenobarbitone Jan 1,2002 GSR 170(E)

with Ergotamine and/or Belladona dt.12.3.01

10.Fixed dose combination of Haloperidol Jan 1,2002 GSR 170(E)

with any anti-cholinergic agent including dt.12.3.01

Propantheline Bromide.

11.Fixed dose combination of Nalidixic Acid Jan 1,2002 GSR 170(E)

with any anti-amoebic including Metronidazole. dt.12.3.01

12.Fixed dose combination of Loperamide Jan 1,2002 GSR 170(E)

Hydrochloride with Furazolidone dt.12.3.01

13.Fixed dose combination of Cyproheptadine Jan 1,2003 GSR 170(E)

with Lysine or Peptone. dt.12.3.01

14.Astemizole Apr.1,2003 GSR 191(E)

dt.5.3.03

15.Terfinadine Apr.1,2003 GSR 191(E)

dt.5.3.03

16.Fenformin Oct.1,2003 GSR 780(E)

dt.1.10.03

17.Rofecoxib Dec 13,2004 GSR 810(E)
dt. 13.12.04

18.Valdecoxib July 25,2005 GSR 510(E)
and it's formulation dt. 25.07.05

National Pharmacovigilance Program (INDIA)

 

            India has more than half a million qualified Doctors and15,000 hospitals having bed strength of 6,24,000.  It is the fourth largest producer of pharmaceuticals in the world. It is emerging as an important Clinical trial hub in the world. Many new drugs are being introduced in our country. Therefore, there is a need for a vibrant pharmacovigilance system in the country to protect the population from the potential harm that may be caused by some of these new drugs.

 

            Clearly aware of the enormity of task the Central Drugs Standard Control Organization (CDSCO) has initiated a well structured and highly participative National Pharmacovigilance Programme. It is largely based on the recommendations

made in the WHO document titled “Safety Monitoring of Medicinal Products –

Guidelines for Setting up and Running a Pharmacovigilance Centre”.

 

            The National Pharmacovigilance Program was officially inaugurated by the Honorable Health Minister Dr.Anbumani Ramadoss on 23 November, 2004 at New Delhi.

            The specific aims of the Pharmacovigilance Programme are to:

·        contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective(including cost effective) use

·        improve patient care and safety in relation to use of medicines and all medical and paramedical interventions

·        improve public health and safety in relation to use of medicines

·        promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public 

 

            The Programme aims to foster the culture of ADE notification in its first year of operation and subsequently aims to generate broad based ADR data on the Indian population and share the information with global health-care community through WHO-UMC

Under the program 26 peripheral centers, 5 Regional Centers and 2 Zonal Centers were established. The Peripheral centers will record the Adverse Events (AE) and send to the Regional Centers. They in turn collate and scrutinize the data received from the Peripheral Centers and submit to the Zonal Centers. The Zonal Centers will analyze the data and submit consolidated information to the National Pharmacovigilance Centre. The Zonal Centre will also provide training, general support and coordinate the functioning of the Regional Centers.

The National Pharmacovigilance Advisory Committee (NPAC) oversee the performance of various Zonal, Regional and Peripheral Pharmacovigilance centers as well as recommend possible regulatory measures based on the data received from various centers. It also oversees data collection and assessment, interpretation of data as well as publication of ADR monitoring data. The Committee also periodically evaluates their protocol compliance levels to ensure that the data received is homogenous and can be scientifically pooled for informed regulatory decisions. Wherever necessary, NPAC also seeks the opinion of experts in various specializations.  

NATIONAL PHARMACOVIGILANCE POLICY

 

            Since there are considerable social and economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management – there is a need to engage health-care professionals and the public at large, in a well structured programme to build synergies for monitoring adverse drug reactions.

           

            The purpose of the programme is to collate data, analyze it and use the inferences to recommend informed regulatory interventions, besides communicating risks to healthcare professionals and the public.

 

The National Pharmacovigilance Programme will have the following milestones:

 

• Short-term objectives: To foster a culture of notification

 

• Medium-term objectives: To engage several healthcare professionals and

            NGOs in the drug monitoring and information dissemination processes.

 

• Long-term objectives: To achieve such operational efficiencies that would make

      Indian National Pharmacovigilance Programme a benchmark for global drug

            monitoring endeavors.

 

NATIONAL PHARMACOVIGILANCE PROGRAMME

 

            Before a product is marketed, experience of its safety and efficacy is limited to its use in clinical trials, which are not reflective of practice conditions as they are limited by the patient numbers and duration of trial as well as by the highly controlled conditions in

which Clinical Trials are conducted.

 

            The conditions under which patients are studied during the pre-marketing phase do not necessarily reflect the way the medicine will be used in the hospital or in general

practice once it is marketed. Information about rare but serious adverse drug reactions,

chronic toxicity, use in special groups (e.g. pregnant women, children, elderly) and drug

interactions are often incomplete or not available. Certain adverse drug reactions may

not be detected until a very large number of people have received the medicine.

Pharmacovigilance is therefore one of the important post-marketing tools in ensuring the safety of pharmaceutical and related health products.

 

            Pharmacovigilance is defined as the detection, assessment and prevention of adverse drug reactions in humans. It is the process of:

 

• Monitoring medicines as used in everyday practice to identify previously

            unrecognized adverse effects or changes in the patterns of their adverse effects

• Assessing the risks and benefits of medicines in order to determine what action,

      if any, is necessary to improve their safe use

• Providing information to users to optimize safe and effective use of medicines
• Monitoring the impact of any action taken

 

FRAMEWORK FOR PHARMACOVIGILANCE IN INDIA

 

            The Central Drugs Standard Control Organization (CDSCO) has initiated a country-wide Pharmacovigilance programme under the aegis of DGHS, Ministry of Health & Family Welfare, Government of India.

 

            The programme is coordinated by the National Pharmacovigilance Centre at

CDSCO. The National Centre is operating under the supervision of the National

Pharmacovigilance Advisory Committee to recommend procedures and guidelines for

regulatory interventions.

 

THE NATIONAL PHARMACOVIGILANCE CENTRE AT CDSCO

 

The National Pharmacovigilance Centre is based at CDSCO and shall:

 

1. monitor the adverse drug reactions of medicines in order to identify previously unexpected adverse drug reactions or indicate that certain reactions occur more commonly than previously believed. This will include the collation, review and evaluation of all spontaneous ADR reports received by the unit on a nation-wide basis. This information will then be keyed into the ADR database for use in           aggregate analysis. These reports shall also be submitted to the WHO International             Drug Monitoring Programme for international collaboration on drug safety.

 

2. review Periodic Safety Update Reports (PSURs) submitted by pharmaceutical companies. Pharmaceutical companies are required to submit the PSURs of all new chemicals drugs. PSURs shall be expected to be submitted every 6 monthly for the first 2 years of marketing in India, and annually for the subsequent 2 years.

 

3. maintain contacts with international regulatory bodies working in pharmacovigilance and exchange information on drug safety.

 

4. assess the regulatory information relating to safety in order to determine what             action, if necessary, needs to be taken to improve safe use. Based on the available data, the Advisory Committee shall make recommendations on product label amendments, product withdrawals and suspension.

 

5. provide information to end-users through adverse drug reaction news, bulletins, drug  alerts and seminars.

 

For further information please contact:

 

The National Pharmacovigilance Centre

Office of Drugs Controller General of India,

Central Drugs Standard Control Organization,

Room No. 347-A,

D.G.H.S., Ministry of Health & Family Welfare

Nirman Bhawan, New Delhi 110 011.

Tel: (11) 23018806 Fax: (11) 23012648

Email: dci@nb.nic.in www.cdsco.nic.in

 

Glossary of terms

 

National Pharmacovigilance Programme (NPP)

The nation wide programme, sponsored and coordinated by the country’s central drug

regulatory agency – Central Drugs Standard Control Organization (CDSCO) – to

establish and manage a data base of Adverse Drug Reactions (ADR) for making

informed regulatory decisions regarding marketing authorization of drugs in India for

ensuring safety of drugs.

 

Peripheral Pharmacovigilance Centers (PPC)

Primary pharmacovigilance centers. Relatively smaller medical institutions including

individual medical practitioners’ clinics, private hospitals, nursing homes, pharmacies

etc. First contact ADR data collection unit at a health care facility. They would be identified and coordinated by RPCs / ZPCs in consultation with CDSCO.

 

Regional Pharmacovigilance Centers (RPC)

Secondary pharmacovigilance centers. Relatively larger healthcare facilities attached

with medical colleges. They would act as second level centers in the administrative

structure of the NPPI. They will function as first contact ADE data collection units also.

They would be identified and coordinated by ZPCs in consultation with the CDSCO.

 

Zonal Pharmacovigilance Centre (ZPCs)

Tertiary pharmacovigilance centers. Large healthcare facilities attached with medical colleges in metro cities identified by the CDSCO for the purpose. They would act as third level centers in the administrative structure of the NPPI. They will function as First contact ADE data collection units also.

 

Coordinator

Designated in-charge of a particular participating PVig centre

 

Investigator

A healthcare professional involved in investigation of drug related adverse events.

 

Notifier

Any person who suspects to have experienced / observed an ADE and informs any

participating Pharmacovigilance centre about it.

 

Reporter

A healthcare professional reporting ADR on the ADR form.

 

Monitoring

The process of overseeing drug related adverse events at the PVigC participating in

the PVig Programme.

 

Reporting

The process of providing ADR information by filling in the ADR form appropriately and

forwarding the same to the appropriate level.

 

Notification

Process of informing by a notifier to any participating pharmacovigilance centre about the occurrence of a suspected ADR. The process may involve informing over telephone, in person, email, fax or any other means of communication-verbal or written. All notifiers must give their contact details. Appropriate and adequate measures must be taken to keep track of the notifier. Any follow up action will be initiated on a notification only after the due verification of the notifier. If the notifier cannot be traced back, it will be recorded on the notification slip before closing the case.

 

Notification slip

A pre-designed structured form made available by the NPPI for written communication of a suspected ADR by the notifier duly signed by him/her wherever feasible.

 

ADR Form

It’s the pre-designed structured form issued by NPPI to record ADR.

 

Archiving

This is to be done at the Regional / Zonal Centers for a period of 5 years

 

Audit

A systematic and independent examination (conducted by personnel, independent of the centre) of center’s activities and documents to determine whether center’s activities were conducted and the data were recorded, analysed and accurately reported according to the protocol

 

Confidentiality

In a confidential / secretive manner.

 

Side Effect

Any unintended effect of a pharmaceutical product occurring at doses normally used in

man which is related to the pharmacological properties of the drug.

Comment: This is an old term and is broad enough to include both positive and negative effects of a drug apart from its main properties or indications. Some use the term as synonymous with 'adverse reaction', but the proposed definition will improve clarity of use of this term.

 

Adverse Event / Adverse Experience

Any untoward medical occurrence that may present during treatment with a pharmaceutical product at the same time, does not necessarily have a causal relationship with this treatment.

Comment: This is a more recent term which some use interchangeably with 'adverse reaction', but, as indicated, it is better reserved for clinical phenomena occurring during drug treatment where causality cannot be or is not ascertained.

 

Signal

Reported information on a possible causal relationship between an adverse event and

a drug, the relationship being unknown or incompletely documented previously. Usually

more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.

Comment: This describes the first alert of a problem with a drug. By its nature a signal cannot be regarded as definitive but indicates the need for further enquiry or action. On the other hand it is prudent to avoid a multiplicity of signals based on single case reports since follow up of all such would be impractical and time consuming. The definition allows for some flexibility in approach to a signal based on the characteristics of individual problems. Some would like a 'signal' to include new information on positive drug effects, but this is outside the scope of a drug safety Programme.

 

Adverse Reaction

WHO Technical Report No 498 (1972); 'A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

Comment: This basic definition includes all doses prescribed clinically, but is intended

to exclude accidental or deliberate overdose. The sub classification of 'unexpected' was

included to facilitate understanding of the type of adverse reaction which is most

important to report to drug monitoring agencies.

 

Unexpected Adverse Reaction

An adverse reaction, the nature or severity of which is not consistent with domestic

labeling or market authorization, or expected from characteristics of the drug.

 

Serious Adverse Event or Reaction

A serious adverse event or reaction is any untoward medical occurrence that at any dose:

• results in death
• requires inpatient hospitalization or prolongation of existing hospitalization
• results in persistent or significant disability/incapacity
• is life-threatening

To avoid any confusion or misunderstanding of the difference between the terms

'serious' and 'severe', the following note of clarification is provided:

The term 'severe' is not synonymous with serious. 'Severe' is used to describe the

intensity (severity) of a specific event (as in mild, moderate or severe); the event itself,

however, may be of relatively minor medical significance (such as severe headache).

Seriousness (not severity) which is based on patient/event outcome or action criteria

serves as guide for defining regulatory reporting obligations.

(Source: National Pharmacovigilance Protocol, Ministry of Health & Family Welfare, Govt. of India)

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Abbott received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin - the most commonly prescribed dose of simvastatin - with either 500 mg or 1,000 mg of niacin extended-release...

Abraxis BioScience And Specialised Therapeutics Announce Approval To Market ABRAXANE For Metastatic Breast Cancer In New Zealand

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy...

Abbott's SIMCOR ® ( Niacin Extended-release / Simvastatin ) Receives FDA Approval For New Dosage Strengths

Abbott (NYSE: ABT) received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin the most commonly prescribed dose of simvastatin with either 500 mg or 1,000 mg of niacin extended-release...

Advanced Life Sciences Applies For FDA Fast-Track Designation For Restanza In CABP

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced that the Company has applied to the U.S...

FDA Approves Drug For Chronic Drooling In Children

The U.S. Food and Drug Administration approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years. Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow...

New Early Detection System Helps FDA Identify More Than 100 Food Safety Problems In First 7 Months

More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration's new electronic portal in its first months of operation, the agency said today...

FDA RECALLS . . . .

FDA Recalls

Lundbeck Inc. Announces the Voluntary Nationwide Recall of Two Lots of NeoProfen® (ibuprofen lysine) Injection

– Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage.

Lundbeck Inc. Announces the Voluntary Nationwide Recall of Two Lots of NeoProfen® (ibuprofen lysine) Injection Recall will Result in Temporary Product Shortage

– Lundbeck Inc. has voluntarily recalled two lots of NeoProfen® (ibuprofen lysine) Injection that failed to meet a visible particulate quality requirement. These two lots are the only lots currently available to prescribers and therefore the recall will result in a temporary drug shortage. This voluntary recall is the result of the company’s inspections of the two product lots of NeoProfen.

Bay Valley Foods Issues Allergy Alert on Undeclared Egg and Wheat in Cans of Mislabeled Chef's Cupboard Chicken with Rice Soup

Bay Valley Foods is voluntarily recalling 10.5 oz cans of Chef's Cupboard Chicken with Rice Soup because some cans are mislabeled and may contain Vegetarian Vegetable Soup. The mislabeled product contains undeclared egg and wheat.

Nutraloid Labs Inc. Conducts Voluntary Nationwide Recall of Two Dietary Supplements Found to Contain Undeclared Drug Ingredient

Nutraloid Labs Inc. announced today that it is conducting a voluntary nationwide recall of two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II.

Nutraloid Labs Inc.

Specialty Farms, LLC Expands Recall of Organic Alfalfa Sprouts Blend and Organic Sprout Salad in the North Eastern United States Because of Possible Health Risk

Specialty Farms is voluntarily recalling certain Alfalfa sprout products with a best if sold by date of “8/3/2010” and “8/1/2010” that has the potential to be contaminated with Listeria Monocytogenes (LM). Listeria Monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Dulcería Chepito Emite una Alerta por Alergenos en Sus Productos "Almejas"

Dulcería Chepito localizada en Cabo Rojo, PR está llevando a cabo un recogido voluntario del producto "Chepito Dulces Tropicales - Almejas" empacados en unidades de 6 oz. Este producto contiene huevos y no está declarado en la etiqueta. Personas que son alérgicas al huevo están en riesgo de serias reacciones alérgicas si consumen estos productos.

Biggers & Callaham, Llc Dba Mice Direct Recalls Frozen Reptile Feed Because Of Possible Health Risk

Biggers & Callaham LLC., D/B/A Mice Direct of Cleveland Georgia is recalling frozen reptile feed (mice, rats, chicks), because it has the potential to be contaminated with Salmonella . Salmonella can affect animals and there is risk to humans from handling contaminated pet products.

Voluntary Recall of PreserVision® Eye Vitamin AREDS 2 Formula in the United States

Bausch + Lomb is conducting a voluntary recall of its PreserVision® Eye Vitamin AREDS 2 Formula with Omega 3 soft gels, only available within the United States.

Bausch + Lomb chose to initiate this recall based on a small number of reports predominantly within a specific age group, age 70 and older, who reported difficulty swallowing or a choking sensation when taking the soft gel.

P&G Recalls Two Lots of Prescription Renal Diet Cat Food due to a Possible Health Risk

The Procter & Gamble Company (P&G) (NYSE:PG), is voluntarily recalling two specific lots of its prescription renal dry cat food as a precautionary measure, as it has the potential to be contaminated with salmonella. The following products are included...

Airgas South Initiates Precautionary Voluntary Recall of Medical Gas Products at Chattanooga, TN Facility

Airgas South, Inc., a distributor of industrial, medical, and specialty gases, today announced an expanded voluntary recall of medical gas products filled at its Chattanooga, Tennessee facility.

Pasco Processing LLC, Announces Voluntary Product Recall Because of Possible Health Risk

Pasco Processing, LLC, Pasco WA is recalling 2087 cases of 20lb. bulk packaged Corn and Poblano peppers, (SKU 10071179017738) because of the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.

Specialty Farms, LLC Recalls Organic Alfalfa Sprouts Blend and Organic Sprout Salad in the North Eastern United States Because of Possible Health Risk

Specialty-Farms, LLC is voluntarily recalling Specialty Farms brand Organic Alfalfa Sprouts Blend and Organic Sprout Salad, as noted below. These items both have a "sell-by date of 7/26/2010" and are net weight 4 ounces in plastic containers...

Quong Hop & Co. Recalls Raquel's Products (Because Of Potential Health Risk)

South San Francisco, CA - Quong Hop & Co.

Oregon Ice Cream Company Issues Allergy Alert on Undeclared Peanuts in Denali Bear Claw Ice Cream

Oregon Ice Cream Company LLC of Eugene, OR is voluntarily recalling 641 tubs of 3 gallon Denali Bear Claw ice cream, because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products...

DeBoles® Nutritional Foods, Inc. Voluntarily Recalls One Lot Code of DeBoles® Kids Only! Gluten Free Tubettini Corn Pasta Due to the Presence of an Undeclared Allergen, Lot Code 30JUN11D1

DeBoles Nutritional Foods, Inc. announced that it is recalling one lot code of DeBoles® Kids Only! Gluten Free Tubettini Corn Pasta because it may contain undeclared whole wheat alphabet pasta. People who are allergic to wheat run the risk of an allergic reaction, which may be serious or life-threatening if they consume the recalled product.

J & H Besta Corp. Issues a Voluntary Nationwide Recall of Joyful Slim Herb Supplement Found to Contain an Undeclared Drug Ingredient

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Joyful Slim Herb Supplement distributed by the company was found to contain undeclared Desmethyl Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.

Cook Initiates Voluntary Recall of Certain Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that Contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube

Cook has initiated a voluntary recall of certain lots of its Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube.

Good Health, Inc. Issues a Nationwide Voluntary Recall of Product Marketed as Dietary Supplement

Good Health, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement Vialipro for sexual enhancement sold under the Lot Numbers listed below .

This product is currently being sold as a dietary supplement throughout the U.S. Good Health, Inc.

J & H Besta Corp. Issues a Voluntary Nationwide Recall of Slim- 30 Herb Supplement Found to Contain an Undeclared Drug Ingredient

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.

D & M Smoked Fish, Inc. Issues an Allert on Uneviscerated Schmaltz Herring

D & M Smoked Fish, Inc. located in Queens, New York, is recalling Haifa brand vacuum packaged Schmaltz Herring with the lot number 168, because the product was found to be uneviscerated.

FDA MEDICINE WATCH . . . .

FDA MedWatch

Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

Increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.

Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

Product sold online as a dietary supplement. When consumed as instructed, produces an industrial bleach that can cause serious harm to health.

Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient

s

These products, marketed as dietary supplements, contain sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerously low levels.

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.

Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient

Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke.

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Recall due to balloon inflation assembly that may not hold air

CONSTELLATION Vision System: Recall

Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.

Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.

Slim- 30 Herb Supplement: Undeclared Drug Ingredient

Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

A recently published study suggested use of ARBs may be associated with a small increased risk of cancer.

Coumadin 1 mg Tablet Blister Packs: Recall

Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.

Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

Warning highlights the risk of severe liver injury and how this risk may be reduced.

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.

Que She Herbal Supplement: Undeclared Drug Ingredients

Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.

Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.

Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall

The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

A power supply assembly failure can result in the inability to deliver defibrillation therapy.

Mylotarg (gemtuzumab ozogamicin): Market Withdrawal

Drug failed to demonstrate clinical benefit to patients enrolled in trials.