January
Brentuximab Vedotin
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin)Prescribing Information
Glucarpidase Injection
FDA Approves Voraxaze (glucarpidase) to Treat Patients with Toxic Methotrexate Levels
Tenofovir
U.S. Food and Drug Administration Approves New Formulations of Viread (tenofovir disoproxil fumarate) for Use by Children Living With HIV
Bortezomib
FDA Approves Subcutaneous Administration of Velcade (bortezomib) In All Approved Indications
Ciclesonide
FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis
Ezetimibe and simvastatin
New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
Levetiracetam
UCB Announces FDA Approval for Keppra (levetiracetam) in Infants and Children from One Month of Age with Partial Onset Seizures
Ingenol Mebutate Topical Gel
FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
Axitinib Tablets
FDA Approves Inlyta (axitinib) for Advanced Renal Cell Carcinoma Exenatide
FDA Approves Bydureon (exenatide) - The First and Only Once-Weekly Treatment for Type 2 Diabetes
Vismodegib
FDA Approves Erivedge (vismodegib) for Basal Cell Carcinoma
Ivacaftor
FDA Approves Kalydeco (ivacaftor) to Treat Rare Form of Cystic Fibrosis
Imatinib
FDA Approves Gleevec (imatinib mesylate) for Expanded Use in Patients with Rare Gastrointestinal Cancer
Linagliptin And Metformin Hydrochloride
FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes
February
Sitagliptin-Metformin
FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience
Lisdexamfetamine
Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD
Ivermectin
Sanofi Announces FDA Approval of Sklice (ivermectin)Lotion for the Treatment of Head Lice
Mitomycin
Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol (mitomycin)
March
Influenza Virus Vaccine
FDA Approves FluMist (Influenza Virus Vaccine, Live, Intranasal) to Prevent Seasonal Influenza
Pancrelipase
Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules
Lucinactant
Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome
Dienogest And Estradiol Valerate
U.S. FDA Approves Natazia (dienogest and estradiol valerate) First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)
Alendronate
FDA Approves Binosto(alendronate), First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
Beclomethasone Dipropionate
Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis
Etravirine
FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review
Peginesatide
Affymax and Takeda Announce FDA Approval of Omontys (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis
April
Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) Pregnancy Category Change for Women with Diabetes
Rotigotine
Neupro (Rotigotine )Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome
Everolimus
Novartis drug Afinitor ( Everolimus) approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC
Pazopanib
FDA Approves Votrient ( Pazopanib) for Advanced Soft Tissue Sarcoma
Avanafil
FDA Approves Stendra ( Avanafil) for Erectile Dysfunction Levofloxacin
FDA Approves Levaquin (Levofloxacin) as an Antibacterial Treatment for Plague
Florbetapir F 18
FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Liraglutide
Victoza (Liraglutide) Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia
May
Taliglucerase Alfa
FDA Approves New Orphan Drug Elelyso (Taliglucerase alfa) to Treat a Form of Gaucher Disease
Azelastine And Fluticasone
MEDA Announces Dymista (Azelastine and Fluticasone) Approved by the FDA for Allergic Rhinitis
Tazarotene
Fabior (tazarotene) FDA Approval History for acne Pancrelipase
Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
June
Gabapentin Enacarbil
GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
Pertuzumab
FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine
MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)
Pregabalin
FDA Approved Lyrica (Pregabalin) For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review
Immune Globulin Infusion (Human)
Baxter Announces FDA Approval for Gammagard Liquid ( immune globulin infusion (human)) as a Treatment for Multifocal Motor Neuropathy
Lorcaserin
FDA Approves Belviq (Lorcaserin) to Treat Some Overweight or Obese Adults
July
Prednisone
Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications
Emtricitabine And Tenofovir
FDA Approves Truvada (emtricitabine and tenofovir) for Reducing the Risk of Sexually Acquired HIV Infection
Sodium Picosulfate, Magnesium Oxide And Citric Acid
FDA Approves Prepopik(sodium picosulfate, magnesium oxide and citric acid) for Oral Solution for
Colonoscopy Prep
Phentermine And Topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)
Carfilzomib
FDA Approves Kyprolis (carfilzomib) for Patients with Advanced Multiple Myeloma
Everolimus
FDA Approves Afinitor (everolimus) for Advanced Breast Cancer
Aclidinium Bromide
FDA Approves Tudorza (aclidinium bromide) Pressair to Treat Chronic Obstructive Pulmonary Disease
Icosapent Ethyl
Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia
Emtricitabine And Tenofovir
FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection
phentermine and topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)
August
Ziv-Aflibercept
FDA Approves Zaltrap (ziv-aflibercept) for Metastatic Colorectal Cancer
Vincristine Sulfate Liposomes
FDA Approves Marqibo (vincristine sulfate liposomes) for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
Ranibizumab
FDA Approves Lucentis (ranibizumab injection) for Treatment of Diabetic Macular Edema (DME)
Epinephrine
Sanofi Announces FDA Approval for Auvi-Q(epinephrine), First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies
Linagliptin
FDA approves updated prescribing information for Tradjenta (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes
Buprenorphine And Naloxone
Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone (buprenorphine and naloxone) Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence
Hydromorphone
FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain
Cobicistat-Elvitegravir-Emtricitabine-Tenofovir
FDA Approves New Combination Pill Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir)for HIV Treatment
Tapentadol
FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Everolimus
FDA Approves Afinitor Disperz (everolimus)- First Drug Formulated for Children with Rare Brain Tumor
Tbo-Filgrastim
FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
Linaclotide
FDA Approves Linzess (linaclotide)to Treat Certain Cases of Irritable Bowel Syndrome and Constipation
Enzalutamide
FDA Approves Xtandi (enzalutamide)for Late-Stage Castration-Resistant Prostate Cancer
September
Rivastigmine
Higher Dose of Novartis Drug Exelon (rivastigmine) Patch Approved By FDA for Patients With Mild to Moderate Alzheimer's Disease
Bosutinib
FDA Approves Bosulif (bosutinib)for Chronic Myelogenous Leukemia
Teriflunomide
FDA Approves New Multiple Sclerosis Treatment Aubagio (teriflunomide)
Denosumab
FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture
Regorafenib
FDA Approves Stivarga (regorafenib) for Advanced Colorectal Cancer
Adalimumab
FDA Approves Humira (adalimumab) to Treat Ulcerative Colitis
Methylphenidate
NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR(methylphenidate) for Once-Daily Treatment of ADHD
October
Cysteamine Ophthalmic Solution
Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution)
0.44% Paclitaxel Protein-Bound
FDA Approves Abraxane (paclitaxel protein-bound) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Ocriplasmin
FDA Approves Jetrea (ocriplasmin) for Symptomatic Vitreomacular Adhesion in the Eyes
Perampanel
FDA Approves Fycompa (perampanel) to Treat Seizures
Omacetaxine Mepesuccinate
FDA Approves Synribo (omacetaxine mepesuccinate) for Chronic Myelogenous Leukemia
November
Rivaroxaban
FDA Expands Use of Xarelto (rivaroxaban) to Treat, Reduce Recurrence of Blood Clots
Tofacitinib
FDA Approves Xeljanz (tofacitinib) for Rheumatoid Arthritis
DECEMBER
The following drugs have recently been approved by the FDA.
Sirturo (bedaquiline)
Date of Approval: December 31, 2012
as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
Eliquis (apixaban) Tablets
Date of Approval: December 28, 2012
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
Adasuve (loxapine) Inhalation Powder
Date of Approval: December 21, 2012
Treatment for: Agitation, Schizophrenia, Bipolar Disorder
Juxtapid (lomitapide) Capsules
Date of Approval: December 21, 2012
Treatment for: Homozygous Familial Hypercholesterolemia
Gattex (teduglutide) for Injection
Date of Approval: December 21, 2012
Treatment for: Short Bowel Syndrome
Bivigam (immune globulin intravenous) Infusion
Date of Approval: December 21, 2012
Treatment for: Primary Immunodeficiency Syndrome
Varizig (varicella zoster immune globulin) for Injection
Date of Approval: December 20, 2012
Treatment for: Varicella-Zoster
Iclusig (ponatinib) Tablets
Date of Approval: December 14, 2012
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Signifor (pasireotide) Injection
Date of Approval: December 14, 2012
Treatment for: Cushing's Syndrome
Evarrest (fibrin sealant) Patch
Date of Approval: December 5, 2012
Treatment for: Bleeding
Regards
Gaurav Taneja,
Pharmafrontiers.
Brentuximab Vedotin
Seattle Genetics Announces Updates to Adcetris (brentuximab vedotin)Prescribing Information
Glucarpidase Injection
FDA Approves Voraxaze (glucarpidase) to Treat Patients with Toxic Methotrexate Levels
Tenofovir
U.S. Food and Drug Administration Approves New Formulations of Viread (tenofovir disoproxil fumarate) for Use by Children Living With HIV
Bortezomib
FDA Approves Subcutaneous Administration of Velcade (bortezomib) In All Approved Indications
Ciclesonide
FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis
Ezetimibe and simvastatin
New FDA Approved Labeling For Vytorin (ezetimibe/simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
Levetiracetam
UCB Announces FDA Approval for Keppra (levetiracetam) in Infants and Children from One Month of Age with Partial Onset Seizures
Ingenol Mebutate Topical Gel
FDA Approves Picato (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
Axitinib Tablets
FDA Approves Inlyta (axitinib) for Advanced Renal Cell Carcinoma Exenatide
FDA Approves Bydureon (exenatide) - The First and Only Once-Weekly Treatment for Type 2 Diabetes
Vismodegib
FDA Approves Erivedge (vismodegib) for Basal Cell Carcinoma
Ivacaftor
FDA Approves Kalydeco (ivacaftor) to Treat Rare Form of Cystic Fibrosis
Imatinib
FDA Approves Gleevec (imatinib mesylate) for Expanded Use in Patients with Rare Gastrointestinal Cancer
Linagliptin And Metformin Hydrochloride
FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes
February
Sitagliptin-Metformin
FDA Approves Janumet XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of Janumet (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience
Lisdexamfetamine
Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD
Ivermectin
Sanofi Announces FDA Approval of Sklice (ivermectin)Lotion for the Treatment of Head Lice
Mitomycin
Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol (mitomycin)
March
Influenza Virus Vaccine
FDA Approves FluMist (Influenza Virus Vaccine, Live, Intranasal) to Prevent Seasonal Influenza
Pancrelipase
Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules
Lucinactant
Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome
Dienogest And Estradiol Valerate
U.S. FDA Approves Natazia (dienogest and estradiol valerate) First and Only Oral Contraceptive Demonstrated to Treat Heavy Menstrual Bleeding (HMB)
Alendronate
FDA Approves Binosto(alendronate), First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
Beclomethasone Dipropionate
Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis
Etravirine
FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review
Peginesatide
Affymax and Takeda Announce FDA Approval of Omontys (peginesatide) Injection for the Treatment of Anemia Due to Chronic Kidney Disease (CKD) in Adult Patients on Dialysis
April
Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) Pregnancy Category Change for Women with Diabetes
Rotigotine
Neupro (Rotigotine )Approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome
Everolimus
Novartis drug Afinitor ( Everolimus) approved by FDA as first medication to treat patients with non-cancerous kidney tumors associated with TSC
Pazopanib
FDA Approves Votrient ( Pazopanib) for Advanced Soft Tissue Sarcoma
Avanafil
FDA Approves Stendra ( Avanafil) for Erectile Dysfunction Levofloxacin
FDA Approves Levaquin (Levofloxacin) as an Antibacterial Treatment for Plague
Florbetapir F 18
FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Liraglutide
Victoza (Liraglutide) Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia
May
Taliglucerase Alfa
FDA Approves New Orphan Drug Elelyso (Taliglucerase alfa) to Treat a Form of Gaucher Disease
Azelastine And Fluticasone
MEDA Announces Dymista (Azelastine and Fluticasone) Approved by the FDA for Allergic Rhinitis
Tazarotene
Fabior (tazarotene) FDA Approval History for acne Pancrelipase
Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
Insulin Detemir
FDA Approves Levemir ( Insulin Detemir) for Expanded Use in Children Two to Five Years of Age with Type 1 Diabetes
June
Gabapentin Enacarbil
GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
Pertuzumab
FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
Meningococcal Groups C And Y And Haemophilus B Tetanus Toxoid Conjugate Vaccine
MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)
Pregabalin
FDA Approved Lyrica (Pregabalin) For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review
Immune Globulin Infusion (Human)
Baxter Announces FDA Approval for Gammagard Liquid ( immune globulin infusion (human)) as a Treatment for Multifocal Motor Neuropathy
Lorcaserin
FDA Approves Belviq (Lorcaserin) to Treat Some Overweight or Obese Adults
July
Prednisone
Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications
Emtricitabine And Tenofovir
FDA Approves Truvada (emtricitabine and tenofovir) for Reducing the Risk of Sexually Acquired HIV Infection
Sodium Picosulfate, Magnesium Oxide And Citric Acid
FDA Approves Prepopik(sodium picosulfate, magnesium oxide and citric acid) for Oral Solution for
Colonoscopy Prep
Phentermine And Topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)
Carfilzomib
FDA Approves Kyprolis (carfilzomib) for Patients with Advanced Multiple Myeloma
Everolimus
FDA Approves Afinitor (everolimus) for Advanced Breast Cancer
Aclidinium Bromide
FDA Approves Tudorza (aclidinium bromide) Pressair to Treat Chronic Obstructive Pulmonary Disease
Icosapent Ethyl
Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia
Emtricitabine And Tenofovir
FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection
phentermine and topiramate
FDA Approves Weight-Management Drug Qsymia (phentermine and topiramate)
August
Ziv-Aflibercept
FDA Approves Zaltrap (ziv-aflibercept) for Metastatic Colorectal Cancer
Vincristine Sulfate Liposomes
FDA Approves Marqibo (vincristine sulfate liposomes) for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
Ranibizumab
FDA Approves Lucentis (ranibizumab injection) for Treatment of Diabetic Macular Edema (DME)
Epinephrine
Sanofi Announces FDA Approval for Auvi-Q(epinephrine), First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies
Linagliptin
FDA approves updated prescribing information for Tradjenta (linagliptin) tablets for add-on therapy to insulin in adults with type 2 diabetes
Buprenorphine And Naloxone
Reckitt Benckiser Pharmaceuticals Inc. Announces FDA Approval of Two New Dosage Strengths of Suboxone (buprenorphine and naloxone) Sublingual Film (C-III) for Maintenance Treatment of Opioid Dependence
Hydromorphone
FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain
Cobicistat-Elvitegravir-Emtricitabine-Tenofovir
FDA Approves New Combination Pill Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir)for HIV Treatment
Tapentadol
FDA Approves Nucynta ER (tapentadol) Extended-Release Oral Tablets for the Management of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Everolimus
FDA Approves Afinitor Disperz (everolimus)- First Drug Formulated for Children with Rare Brain Tumor
Tbo-Filgrastim
FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
Linaclotide
FDA Approves Linzess (linaclotide)to Treat Certain Cases of Irritable Bowel Syndrome and Constipation
Enzalutamide
FDA Approves Xtandi (enzalutamide)for Late-Stage Castration-Resistant Prostate Cancer
September
Rivastigmine
Higher Dose of Novartis Drug Exelon (rivastigmine) Patch Approved By FDA for Patients With Mild to Moderate Alzheimer's Disease
Bosutinib
FDA Approves Bosulif (bosutinib)for Chronic Myelogenous Leukemia
Teriflunomide
FDA Approves New Multiple Sclerosis Treatment Aubagio (teriflunomide)
Denosumab
FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture
Regorafenib
FDA Approves Stivarga (regorafenib) for Advanced Colorectal Cancer
Adalimumab
FDA Approves Humira (adalimumab) to Treat Ulcerative Colitis
Methylphenidate
NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR(methylphenidate) for Once-Daily Treatment of ADHD
October
Cysteamine Ophthalmic Solution
Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution)
0.44% Paclitaxel Protein-Bound
FDA Approves Abraxane (paclitaxel protein-bound) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Ocriplasmin
FDA Approves Jetrea (ocriplasmin) for Symptomatic Vitreomacular Adhesion in the Eyes
Perampanel
FDA Approves Fycompa (perampanel) to Treat Seizures
Omacetaxine Mepesuccinate
FDA Approves Synribo (omacetaxine mepesuccinate) for Chronic Myelogenous Leukemia
November
Rivaroxaban
FDA Expands Use of Xarelto (rivaroxaban) to Treat, Reduce Recurrence of Blood Clots
Tofacitinib
FDA Approves Xeljanz (tofacitinib) for Rheumatoid Arthritis
DECEMBER
The following drugs have recently been approved by the FDA.
Sirturo (bedaquiline)
Date of Approval: December 31, 2012
as part of combination therapy to treat adults with multi-drug resistant pulmonary tuberculosis (TB) when other alternatives are not available.
Eliquis (apixaban) Tablets
Date of Approval: December 28, 2012
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
Adasuve (loxapine) Inhalation Powder
Date of Approval: December 21, 2012
Treatment for: Agitation, Schizophrenia, Bipolar Disorder
Juxtapid (lomitapide) Capsules
Date of Approval: December 21, 2012
Treatment for: Homozygous Familial Hypercholesterolemia
Gattex (teduglutide) for Injection
Date of Approval: December 21, 2012
Treatment for: Short Bowel Syndrome
Bivigam (immune globulin intravenous) Infusion
Date of Approval: December 21, 2012
Treatment for: Primary Immunodeficiency Syndrome
Varizig (varicella zoster immune globulin) for Injection
Date of Approval: December 20, 2012
Treatment for: Varicella-Zoster
Iclusig (ponatinib) Tablets
Date of Approval: December 14, 2012
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Signifor (pasireotide) Injection
Date of Approval: December 14, 2012
Treatment for: Cushing's Syndrome
Evarrest (fibrin sealant) Patch
Date of Approval: December 5, 2012
Treatment for: Bleeding
Regards
Gaurav Taneja,
Pharmafrontiers.
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