Monday, January 25, 2010

LIST OF APPROVED DRUGS DURING 2009 (upto 31-10-2009)

Sr.No.
Drug Name
Indication
Approval Date
1.
Zoledronic Acid Injection 5mg/100ml (Addl. Indication)
For the treatement of osteoporosis in post-menopausal women and in men who are at increased risk of fracture, including those with a recent low-trauma hip fracture.
07.01.09
2.
Misoprostol Tablet 600mcg
Addl. Strength
09.01.09
3.
Acebrophylline Syrup 10mg/ ml
For the treatement of adult patients with chronic obstructive pulmonary disease (COPD) and bronchial asthma.
09.01.09
4.
Selamectin Tropical solution (for verterinary use.) 60mg/120mg per ml
(I) For the treatement and lasting prevention of flea infestations,treatment and control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs and cats;
(II) For the treatement and prevention of sarcoptic mange, roundworms and for control of tick infestations in dogs.
09.01.09
5.
Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules
For the treatment of vitamin deficiency states in adults
14.01.09
6.
Metoprolol tartrate tablets 50 mg (Addl. Indication)
Adjunct to the treatement of Hyperthyroidism
14.01.09
7.
Cinacalet (as HCl) Tablet 30/60/90mg
For the treatment of secondary hyper parathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma
14.01.09
8.
Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 200mg/ml (addl. Indication)
For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.
23.01.09
9.
Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml
For symptomatic treatment of constipation in adults
29.01.09
10.
Ranolazine 1000mg ER Tabs (Additional Strength)
Same as approved
31.01.09
11.
Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml
For intradermal implantation and facial soft tissue augmentation
31.01.09
12.
Caspofungin acetate Injection (Addl. Indication)
For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenic patients.
(II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections.
(III) Treatment of Esophageal Candidiasis.
(IV) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole)
31.01.09
13.
Micafungin ( as sodium) Powder for solution for infusion 50mg / vial
For the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT)
31.01.09
14.
Loteprednol Etabonate Nasal spray 0.1% w/v
For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis.
31.01.09
15.
Rasagiline (as mesylate ) Tablet 0.5mg/1mg
For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa.
31.01.09
16.
Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication)
To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
03.02.09
17.
Closantel Injection100mg/ ml (for verterinary use.)
For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals.
05.02.09
18.
Lornoxicam 4mg + Paracetamol 500mg film coated tablets
For the short term use in acute painful & inflammatory conditions in adults
05.02.09
19.
Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution
For cleansing of physically contaminated wounds and for pre-operative disinfection
09.02.09
20.
Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution
For the treatment of dandruff
09.02.09
21.
Doripenem (as monohydrate) Injection 250mg/500mg
For the treatment of nosocomial pneumonia in adults.
16.02.09
22.
Halobetasol Scalp Approved 0.05% w/v
For the relief of inflammatory and puritic manifestation of corticosteroid respensive dermatosis
18.02.09
23.
Nicotine (as Polacrilex) Lozenges 2mg & 4mg
To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
18.02.09
24.
Tranexamic Acid Tab SR 750mg
For the treatment of menorrhagia
20.02.09
25.
Betahistine Mesilate Tablet 6mg/12mg
For the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo.
20.02.09
26.
Abatacept Injection 250mg/vial (Addl. Indication)
In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists
20.02.09
27.
Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial
For the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients.
23.02.09
28.
Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream
For the treatment of patients with skin hyperpigmentation
23.02.09
29.
Doxyphylline 400 mg + Terbutaline 5mg tablets
For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only
23.02.09
30.
Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream
For the treatment of melasma of face in adults
23.02.09
31.
Ketoconazole 2% + Zinc Pyrithone 1% Lotion
For the treatment of pityriasis and dandruff of the scalp
23.02.09
32.
Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral Suspension)
For the treatment of HIV patients
23.02.09
33.
Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets
As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control
23.02.09
34.
Aceclofenac 100mg + Tizanidine 2mg film coated tablets
For the treatment of acute low back pain in adult patients only
23.02.09
35.
Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion
As sunscreen lotion for prevention of sunburn skin
23.02.09
36.
Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup
For the symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired
23.02.09
37.
Lidocaine Lozenges 200/300mg
For single agent anesthesia in upper gastro intestinal endoscopy.
26.02.09
38.
Calamine 8% + Liquid Paraffin10% lotion
As antipruritic and smoothening agent
26.02.09
39.
Nifedipine 0.3% + Lidocaine1.5% cream
For the treatment of anal fissures
26.02.09
40.
Quinapril 20mg + HCTZ 25mg film coated tablet
For the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion
26.02.09
41.
Levodopa 100/100/250 + Carbidopa 10/25/25mg mouth dissolving tablet
For the symptomatic symptoms of idiopathic Parkinson's Disease
04.03.09
42.
Paliperidone ER Tablets 1.5mg
Addl. Strength
04.03.09
43.
Losartan 100mg+ HCTZ 25 mg tablet
Additional higher strength
16.03.09
44.
Darunavir(as ethanolate) Tablet 300mg
For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents.
19.03.09
45.
Ropivacaine HCl Inj.2/5/7.5/10mg
For the production of local or regional anasthesia for surgery and for acute pain management.
19.03.09
46.
Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug)
As vitamin and phosphorous supplement for livestock, shirmp and fish.
19.03.09
47.
Fluticasone furoate Nasal spray 27.5mcg per spray
For the treatment of symptoms of allergic rhinitis.
19.03.09
48.
Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion
A sunscreen lotion for prevention of sunburn skin
19.03.09
49.
Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet
Additional Strength
19.03.09
50.
Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrup
For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis
19.03.09
51.
Montelucast 4 mg+ Levocetrizine 2.5 mg tablet
Additional lower paedriatric dose
19.03.09
52.
Surgical Sealant
To be indicated for use in sealing suture lines along arterial and venous reconstructions.
26.03.09
53.
Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive)
For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
26.03.09
54.
Bimatoprost Opthalmic solution 0.03%
For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
30.03.09
55.
Trabectedin powder for concentrate for solution for infusion 1 mg/ vial
For the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents.
30.03.09
56.
Acebrophylline Syrup 10mg/ml (Additional Indication)
For the treatment of children (age 6to 12years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma.
30.03.09
57.
Mesalamine PR Tablets 1.2gm
For the induction of remission in patients with active, mild to moderate ulcerative colitis.
30.03.09
58.
Mycophenolate Mofetil Tablets 750mg Additional Strength
Same as approved
31.03.09
59.
Ketorolac Tromethamine Gel 2%w/w
For the treatment of muscle, joint and post-traumatic stress.
31.03.09
60.
Theophylline 400mg SR + Montelukast 10mg Tablet
For the treatment of patients with bronchial asthma
31.03.09
61.
Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.
For the treatment of wound of different etiology
31.03.09
62.
Telmisartan 80mg + Amlodipine 5mg tablet
Additional higher strength
31.03.09
63.
Hyaluronic Acid Sodium Salt
(i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm
(ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg
For the treatment of wound of different etiology
31.03.09
64.
Abatacept Injection 250mg/vial (additional indication)
For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTX
10.04.09

Cetrizine 10 mg + Ambroxol 75 mg SR Tablet
For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired
13.04.2009

Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI
Indicated as third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately.
13.04.2009

Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg
For the tretament of patients with mild to modrate essential hypertension
13.04.2009

Milnacipran 25/50mg Caps (Addl. Indication)
For the management of fibromylagia.
15.04.2009

Lornoxicam SR 16mg Tabs
For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis
25.04.2009

Palonosetron Hcl 0.075mg IV Inj (Addl. Strength)
Same as approved
25.04.2009

Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg
Additional strength
25.04.2009

Albendazole 400 mg + Ivermectin 6 mg tablet
For the treatment of intestinal helminthes and suppression of microfilaraemia especially with bancrofti infections
25.04.2009

Decitabine Lyophilized powder for injection 50mg/20ml vial
For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international Prognostic Scoring System groups.
25.04.2009

Retapamulin Ointment 1%
For the topical treatment of bacterial skin and skin structure infections:- Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses.
25.04.2009

Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+ Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion
For the tretament of pruritis and prickly heat
08.05.2009

Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion
For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults if oral or enteral nutrition is impossible, inadequte or contraindicated.
14.05.2009

Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v
For the topical treatment of the superficial fungal infections of the skin.
02.05.2009

Amlodipine Tablets 5mg/10mg (additional indication)
1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke. 2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease.
02.05.2009

Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication)
Prophylaxis of infection in neck and head surgery
02.05.2009

Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules
For the treatment of chronic idiopathic constipation in adult patients only
16.05.2009

Sucralose
for use as sweetner in drug formulations
09.05.2009

CarvedilolTablets 3.125/6.25/12.5/25mg (additional indication)
To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure)
09.05.2009

Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets
For the treatment of Acute musculoskeletal pain
18.05.2009

Pregabalin SR Tablet 150/300mg
For the treatment of peripheral neuropathic pain in adults
16.05.2009

Guaiphenesin ER Tablet 1200mg
For the treatment of productive cough accompanied by Phlegm
16.05.2009

Everolimus 5/10mg Tablets (Addl. Indication)
Treatment of advance renal cell carcinoma
16.05.2009

Nimesulide ER 200mg
( Additional Indication)
Acute pain in Orthopaedic, ENT, Dental and Post Operative condition
16.05.2009

Palonesetron Injection 0.25mg/5ml (Additional Indication)
For treatment of Post Operative Nausea & vomiting
16.05.2009

Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial
For the treatment of patients with chronic lymphocytic leukemia.
16.05.09

Caffeine(as Citrate) 10mg / ml Injection
For the short term treatment of apnoea of prematurity of infants between 28 and < 33 weeks gestational age.
16.05.09

Perindopril arginine 2.5mg/5mg/10mg film coated tablet
For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.
16.05.09

Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel
For the topical treatment of inflammatory dermatitis with secondry bacterial infection
16.05.09

Mometasone 0.1 % + Fusidic acid 2% cream/ointment
For the treatment of dermatoses where secondry bacterial and/or candidial infection is present
25.04.09

Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets
Additional strength
25.04.09

Methadone Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ 20mg / 40mg tablet
For the treatment of opiod dependence and in maintainence treatment for opioid dependence.
28.05.09

Trospium Chloride film coated tablet 20mg
For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency.
28.05.09

Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution
For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
29.05.09

Zolmitriptan...5.0% w/v Benzalkonium Chloride NF ... 0.01% w/v Nasal spray
For the acute treatment of migraine with or without aura in adults.
29.05.09


Dexmedetomidine ( as HCl) 100mcg /ml Injection
For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting.
29.05.09

Levetiracetam SR Tablet 500/750/1000mg
same as approved

2.05.2009

Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml)
For the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.
3.06.2009


Yttrium-90 Microspheres Injection (Yttrium-90...3GBq (at the time of calibration) per vial)
For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine)
3.06.2009


Luliconazole Cream 1%
For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris.

3.06.2009


Magnesium Valporate Prolonged release tablet 600mg
1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders


4.06.2009

Tenofovir Disoproxil Fumerate 300mg
For the treatment of chronic Hepatitis B in adults
19.6.2009


Bosentan (as monohydrate) Tablets 62.5/125mg
For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve excercise ability and decrease the rate of clinical worsening.

23.6.2009

Lornoxicam 12 mg SR (additional strength)
same as approved
26.6.2009


Azithromycin SR Granules for oral suspension 2000mg
for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis

26.6.2009


Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsules
As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent.
1.07.2009

Methyl Phenidate ER Tablet 10/20/30mg
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
10.07.2009

Dasatinib Tablets 100mg (addl. Strength)
same as approved
10.07.2009


Voglibose 0.2 mg + Metformin 500mg Tablets
As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.
13.7.2009

Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine Composition:
A. combipack of 1 stip of 3 tablets of artesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg
B. combipack of 1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg
C. combipack of 1 stip of 3 tablets of artesunate 100 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of 1 stip of 3 tablets of artesunate 200 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg.
For the treatment of P. falciparum resistant malaria patients

15.7.2009

Milnacipran 100mg (additional Strength)
same as approved
16.7.2009

Rifaximin 400mg (additional Indication)
For the treatment of hepatic encephalopathy
18.7.2009

Nevirapine tablet 50 mg for oral suspension mg
For the treatment of HIV infection in combination with other anti retro viral agents
18.7.2009

Desvenlafaxine (as Succinate) ER Tablets 50mg/100mg
For the treatment of major depressive disorder (MDD)
18.7.2009

Posaconazole Oral Suspension 40mg/ml
For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
18.7.2009

Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form)
same as approved
18.7.2009

Amphotericin B Emulsion 5mg/ml (Addl. Indication)
Febrile Neutropenia in cancer patients
18.7.2009

Hydroxy ethyl starch 10% Solution for infusion
For the treatment of imminent or manifest hypovolemia and shock.
18.7.2009

Naratriptan (as HCl) Tablets 1/ 2.5mg
For the acute treatment of migraine with or without aura in adults.
18.7.2009

Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU (additional Strength)
same as approved
20.7.2009

Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules
For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate
21.7.2009

Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU
Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis
28.7.2009

Ramipril MR capsule 10mg
For the treatment of hypertension/ cardiac failure and myocardial infarction
30.7.2009

Abacavir Sulfate Tablet 60mg
For the treatment of HIV-1 infection in combination with other antiretroviral agents
1.08.2009

Zoledronic Acid Solution for Infusion Addl. Indication
Prevention of clinical fractures after hip fracture in men and women
1.08.2009

Sumatriptan 85 mg + Naproxen 500 mg Tablets
Additional Strength for the treatment of migraine
3.08.2009

Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets
For the treatment of acute inflammation conditions associated with spasm in adults only
3.08.2009

Oxcarbazepine 150/300/600mg Tablet (Addl. Indication
Treatment of generalized tonic-clonic seizures in adults and children
13.08.2009

Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion
for the treatment of diarrhoea of mixed infection in adult patients
17.08.2009

Clozapine Tablet200mg (Addl. Strength)
Indicated in the management of Schizophrenic patients
19.08.2009

Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w
Is indicated for the relief of stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis.
19.08.2009

Enoxaparin Sodium Injection (Addl.Indication)
Treatment of acute ST-segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI)
19.08.2009

Fluvoxamine Maleate100/150mg ER Tablets
For the treatment of obsessive compulsive disorder (OCD)and depression
19.08.2009

Lidocaine Lozenges 200/300mg (Addl. Indication)
For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract.
19.08.2009

Risperidone long acting injection (Addl. Indication)
Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipolar-1 disorder.
29.08.2009

Exemestane 25mg Tablet (Addl. Indication)
Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy.
29.08.2009

Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets
For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups
01.09.2009

Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets
For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function
01.09.2009

Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively (over a period of 7 days).
For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only.
03.09.09

Trospium Chloride ER Capsules 60 mg
For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.
04.09.2009

Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution
For the treatment of nausea and vomiting.
09.09.09

Isosorbibe 20 mg + Hydralazine 37.5 mg tablets
For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status.
18.09.2009

Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets
For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections
22.09.2009

Chlorthalidone Tablet 6.25mg
For the treatment of mild to moderate hypetension.
03.10.09

Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary)
For the treatment of skin bacterial infections in dogs and cats.
03.10.09

Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin
For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats.
03.10.09

Isoflupredone AcetateSuspension for Injection (2mg per ml) (For Veterinary)
For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as:(1) Overwhelming infections with severe toxicity. (2) Bovine ketosis.(3) Musculoskeletal conditions.(4) Shock.(5) Parturient paresis (supportive stress therapy for milk fever).
03.10.09

Saxagliptin (as HCl) 2.5mg/ 5mg Tablets
As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
24.10.09

Calcipotriol Gel 0.005% (additional dosage form)
For the treatment of moderate plaque psoriasis in adults
3.10.2009

Lamotrigine MR Tablets 150mg (Addl. Strength)
same as approved
3.10.2009

Metoprolol Tartrate ER Tablet 75mg (additional strength)
same as approved
3.10.2009

Valganciclovir Powder for Oral Solution 50mg/ml
For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk
9.10.2009

Dexketoprofen Trometamol Gel 12.5mg/gm
For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle
13.10.2009

Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg
For the treatment of mild to moderate severe Alzheimer's Dementia
15.10.2009

Dexketoprofen Trometamol Injection 50mg/2ml
Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain.
22.10.2009

Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication)
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
22.10.2009

Levosulpride ER Tablet 100/150/200mg
For the treatment of depression and schizophrenia in adults
27.10.2009

Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup
Additional strength
27.10.2009

Propofol 10 mg+ Lignocaine 2.5 mg per ml injection
Additional strength
27.10.2009

Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets
For the treatment of diabetic neuropathy
27.10.2009

Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets
For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients
27.10.2009

Reference: http://cdsco.nic.in/listofdrugapprovedmain.html

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