Here is a complete list of drugs approved or extended for use in 2012. The list is complete as published by FDA.
January 2012
Subsys (fentanyl) Sublingual Spray – formerly Fentanyl SL Spray
Date of Approval: January 4, 2012
Company: INSYS Therapeutics, Inc.
Treatment for: Pain
Subsys (fentanyl) is an opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.
Date of Approval: January 4, 2012
Company: INSYS Therapeutics, Inc.
Treatment for: Pain
Subsys (fentanyl) is an opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.
Adcetris (brentuximab vedotin)
Labeling Revision Approved: January 13, 2012
Voraxaze (glucarpidase) Injection
Date of Approval: January 17, 2012
Company: BTG International Inc.
Treatment for: Toxic Methotrexate Levels
Voraxaze (glucarpidase) is a carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function
Viread (tenofovir disoproxil fumarate)
Patient Population Altered: January 18, 2012
Velcade (bortezomib)
New Dosage Regimen: January 23, 2012
Zetonna (ciclesonide) Nasal Aerosol
Date of Approval: January 20, 2012
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Allergic Rhinitis
Zetonna (ciclesonide) is corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis.
Vytorin (ezetimibe/simvastatin)
Labeling Revision Approved: January 24, 2012
Keppra (levetiracetam)
Patient Population Altered: December 16, 2011
Picato (ingenol mebutate) Topical Gel
Date of Approval: January 23, 2012
Company: Leo Pharma
Treatment for: Actinic Keratosis
Picato (ingenol mebutate) is an inducer of cell death indicated for the topical treatment of actinic keratosis
.
Inlyta (axitinib) Tablets
Date of Approval: January 27, 2012
Company: Pfizer Inc.
Treatment for: Renal Cell Carcinoma
Inlyta (axitinib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
Inlyta (axitinib) Tablets
Date of Approval: January 27, 2012
Company: Pfizer Inc.
Treatment for: Renal Cell Carcinoma
Inlyta (axitinib) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.
Bydureon (exenatide) Extended-Release Injectable Suspension
Date of Approval: January 27, 2012
Company: Amylin Pharmaceuticals, Inc. and Alkermes plc
Treatment for: Diabetes Mellitus Type II
Bydureon (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Erivedge (vismodegib) Capsules
Date of Approval: January 30, 2012
Company: Genentech
Treatment for: Basal Cell Carcinoma
Erivedge (vismodegib) is a hedgehog pathway inhibitor for the treatment of patients with advanced basal cell carcinoma (BCC).
Kalydeco (ivacaftor) Tablets
Date of Approval: January 31, 2012
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.
Gleevec (imatinib mesylate)
New Indication Approved: January 31, 2012
Jentadueto (linagliptin and metformin hydrochloride) Tablets
Date of Approval: January 30, 2012
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly
Treatment for: Diabetes Mellitus Type II
Jentadueto (linagliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
February 2012
Janumet (metformin and sitagliptin)
New Formulation Approved: February 2, 2012
New Formulation Approved: February 2, 2012
Vyvanse (lisdexamfetamine dimesylate)
New Indication Approved: January 31, 2012
Sklice (ivermectin) Lotion
Date of Approval: February 7, 2012
Company: Sanofi Pasteur Inc.
Treatment for: Lice
Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older.
Mitosol (mitomycin) Ophthalmic Solution
Date of Approval: February 7, 2012
Company: Mobius Therapeutics, LLC
Treatment for: Glaucoma Surgery
Mitosol (mitomycin) is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.
Zioptan (tafluprost) Ophthalmic Solution – formerly Saflutan
Date of Approval: February 10, 2012
Company: Merck & Co., Inc.
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension
Zioptan (tafluprost ophthalmic solution) is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Bio-T-Gel (testosterone) Topical Gel
Date of Approval: February 14, 2012
Company: BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.
Treatment for: Hypogonadism — Male
Bio-T-Gel (testosterone) is a once-daily transdermal testosterone gel for the treatment of male hypogonadism or low testosterone levels.
Korlym (mifepristone) Tablets
Date of Approval: February 17, 2012
Company: Corcept Therapeutics
Treatment for: Cushing’s Syndrome
Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance.
Angeliq (drospirenone and estradiol)
New Formulation Approved: February 29, 2012
March 2012
FluMist (Influenza Virus Vaccine, Live, Intranasal)
New Formulation Approved: March 1, 2012
New Formulation Approved: March 1, 2012
Ultresa (pancrelipase) Delayed Release Capsules
Date of Approval: March 1, 2012
Company: Aptalis Pharma U.S. Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Ultresa (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Viokace (pancrelipase) Tablets
Date of Approval: March 1, 2012
Company: Aptalis Pharma U.S. Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Viokace (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases. Viokace, in combination with a proton pump inhibitor, is indicated in adults for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy.
Surfaxin (lucinactant) Intratracheal Suspension
Date of Approval: March 6, 2012
Company: Discovery Laboratories, Inc.
Treatment for: Respiratory Distress Syndrome
Surfaxin (lucinactant) is a synthetic, peptide-containing surfactant indicated for the prevention of respiratory distress syndrome (RDS) in premature infants.
Natazia (dienogest and estradiol valerate)
New Indication Approved: March 14, 2012
Treatment for: Contraception, Heavy Menstrual Bleeding
Binosto (alendronate) Effervescent Tablets – formerly EX101
Date of Approval: March 12, 2012
Company: EffRx Pharmaceuticals SA
Treatment for: Osteoporosis
Binosto (alendronate) is a buffered effervescent dosage form of the bisphosphonate drug alendronate sodium administered once weekly for the treatment of osteoporosis.
QNASL (beclomethasone dipropionate) Nasal Aerosol – formerly BDP Nasal HFA
Date of Approval: March 23, 2012
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Allergic Rhinitis
QNASL (beclomethasone dipropionate) is an intranasal corticosteroid non-aqueous “dry” spray formulation for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR).
Intelence (etravirine)
Patient Population Altered: March 26, 2012
Omontys (peginesatide) Injection – formerly Hematide
Date of Approval: March 27, 2012
Company: Affymax, Inc. and Takeda Pharmaceutical Company Limited
Treatment for: Anemia Associated with Chronic Renal Failure
Omontys (peginesatide) an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
April 2012
Levemir (insulin detemir )
Labeling Revision Approved: March 29, 2012
Labeling Revision Approved: March 29, 2012
Neupro (rotigotine)
New Indication Approved: April 2, 2012
Amyvid (florbetapir F 18) Injection
Date of Approval: April 6, 2012
Company: Eli Lilly and Company and Avid Radiopharmaceuticals, Inc.
Treatment for: Diagnostic
Amyvid (florbetapir F 18) is a radioactive diagnostic agent used for brain imaging of beta-amyloid plaques in patients who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline.
Victoza (liraglutide)
Labeling Revision Approved: April 6, 2012
Afinitor (everolimus)
Labeling Revision Approved: April 26, 2012
Votrient (pazopanib)
New Indication Approved: April 26, 2012
Stendra (avanafil) Tablets
Date of Approval: April 27, 2012
Company: Vivus, Inc.
Treatment for: Erectile Dysfunction
Stendra (avanafil) is a phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED).
Levaquin (levofloxacin)
New Indication Approved: April 27, 2012
May 2012
Elelyso (taliglucerase alfa) – formerly Uplyso
Date of Approval: May 1, 2012
Company: Protalix BioTherapeutics, Inc.
Treatment for: Gaucher Disease
Elelyso (taliglucerase alfa) is a plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease.
Date of Approval: May 1, 2012
Company: Protalix BioTherapeutics, Inc.
Treatment for: Gaucher Disease
Elelyso (taliglucerase alfa) is a plant-cell expressed recombinant form of glucocerebrosidase for the treatment of Gaucher disease.
Dymista (azelastine and fluticasone) Nasal Spray
Date of Approval: May 1, 2012
Company: Meda Pharmaceuticals, Inc.
Treatment for: Allergic Rhinitis
Dymista (azelastine and fluticasone) nasal spray is an H1-receptor antagonist and corticosteroid combination indicated for the relief of symptoms of seasonal allergic rhinitis
Fabior (tazarotene) Foam
Date of Approval: May 11, 2012
Company: Stiefel Laboratories, Inc.
Treatment for: Acne
Fabior (tazarotene) Foam is a retinoid indicated for the topical treatment of acne vulgaris.
Pertzye (pancrelipase) Delayed Release Capsules
Date of Approval: May 17, 2012
Company: Digestive Care, Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Pertzye (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
Levemir (insulin detemir )
Patient Population Altered: May 18, 2012
June 2012
Horizant (gabapentin enacarbil)
New Indication Approved: June 6, 2012
New Indication Approved: June 6, 2012
Perjeta (pertuzumab) Injection
Date of Approval: June 8, 2012
Company: Genentech
Treatment for: Breast Cancer
Perjeta (pertuzumab) is a humanized monoclonal antibody indicated in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of HER2-positive metastatic breast cancer.
MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)
Date of Approval: June 14, 2012
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis, Meningococcal Meningitis Prophylaxis
MenHibrix (Hib-MenCY-TT) is a combination vaccine for the active immunization of infants and young children 6 weeks through 18 months of age for the prevention of invasive diseases caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib).
Lyrica (pregabalin)
New Indication Approved: June 20, 2012
Gammagard Liquid (immune globulin infusion (human))
New Indication Approved: June 25, 2012
Belviq (lorcaserin) Tablets – formerly Lorqess
Date of Approval: June 27, 2012
Company: Arena Pharmaceuticals, Inc.
Treatment for: Obesity
Belviq (lorcaserin) is a serotonin 2C receptor agonist indicated for chronic weight management in adults who are obese, or overweight and who have at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol.
Myrbetriq (mirabegron) Extended Release Tablets
Date of Approval: June 28, 2012
Company: Astellas Pharma Inc.
Treatment for: Overactive Bladder
Myrbetriq (mirabegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
July 2012
Truvada (emtricitabine and tenofovir)
New Indication Approved: July 16, 2012
New Indication Approved: July 16, 2012
Prepopik (sodium picosulfate, magnesium oxide and citric acid) for Oral Solution
Date of Approval: July 16, 2012
Company: Ferring Pharmaceuticals
Treatment for: Bowel Preparation
Prepopik (sodium picosulfate, magnesium oxide and citric acid) is a stimulant laxative and osmotic laxative combination indicated for cleansing of the colon as a preparation for colonoscopy in adults.
Qsymia (phentermine and topiramate) Extended-Release Capsules – formerly Qnexa
Date of Approval: July 17, 2012
Company: Vivus, Inc.
Treatment for: Obesity
Qsymia (phentermine and topiramate) is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate extended-release, an antiepileptic drug, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults
.
Kyprolis (carfilzomib) Injection
Date of Approval: July 20, 2012
Company: Onyx Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma.
Afinitor (everolimus)
New Indication Approved: July 20, 2012
Kyprolis (carfilzomib) Injection
Date of Approval: July 20, 2012
Company: Onyx Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Kyprolis (carfilzomib) is a proteasome inhibitor indicated for the treatment of patients with multiple myeloma.
Afinitor (everolimus)
New Indication Approved: July 20, 2012
Tudorza (aclidinium bromide) Pressair
Date of Approval: July 23, 2012
Company: Forest Laboratories, Inc. and Almirall, S.A.
Treatment for: Chronic Obstructive Pulmonary Disease
Tudorza Pressair (aclidinium bromide inhalation powder) is an anticholinergic indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Vascepa (icosapent ethyl) Capsules
Date of Approval: July 26, 2012
Company: Amarin Corporation plc
Treatment for: Hypertriglyceridemia
Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia
Rayos (prednisone) Delayed-Release Tablets – formerly Lodotra
Date of Approval: July 26, 2012
Company: Horizon Pharma, Inc.
Treatment for: Rheumatoid Arthritis, Polymyalgia Rheumatica, Psoriatic Arthritis, Ankylosing Spondylitis, Asthma, Chronic Obstructive Pulmonary Disease
Rayos (prednisone) is a delayed release corticosteroid indicated as an anti-inflammatory or immunosuppressive agent to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease (COPD).
August 2012
Zaltrap (ziv-aflibercept) Injection
Date of Approval: August 3, 2012
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Colorectal Cancer
Zaltrap (ziv-aflibercept) is an angiogenesis inhibitor for the combination treatment of patients with metastatic colorectal cancer.
Date of Approval: August 3, 2012
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Colorectal Cancer
Zaltrap (ziv-aflibercept) is an angiogenesis inhibitor for the combination treatment of patients with metastatic colorectal cancer.
Marqibo (vincristine sulfate liposomes) Injection
Date of Approval: August 9, 2012
Company: Talon Therapeutics Inc.
Treatment for: Acute Lymphoblastic Leukemia
Marqibo (vincristine sulfate liposome injection) is a vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL).
Lucentis (ranibizumab)
New Indication Approved: August 10, 2012
Auvi-Q (epinephrine) Injection
Date of Approval: August 10, 2012
Company: Sanofi
Treatment for: Anaphylaxis, Allergic Reaction
Auvi-Q (epinephrine injection) is a voice-guided epinephrine auto-injector for the emergency treatment of life-threatening allergic reactions in people who are at risk for or have a history of anaphylaxis.
Tradjenta (linagliptin)
Labeling Revision Approved: August 13, 2012
Suboxone (buprenorphine and naloxone)
New Formulation Approved: August 10, 2012
Exalgo (hydromorphone)
New Dosage Form Approved: August 27, 2012
Treatment for: Pain in Opioid Tolerant Patients
Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) Tablets
Date of Approval: August 27, 2012
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) is a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
Nucynta (tapentadol)
New Indication Approved: August 28, 2012
Afinitor (everolimus)
New Dosage Form Approved: August 29, 2012
(tbo-filgrastim) Injection
Date of Approval: August 29, 2012
Company: Sicor Biotech
Treatment for: Neutropenia Associated with Chemotherapy
Tbo-filgrastim is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.
Linzess (linaclotide) Capsules
Date of Approval: August 30, 2012
Company: Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc.
Treatment for: Irritable Bowel Syndrome, Constipation — Chronic
Linzess (linaclotide) is a guanylate cyclase-C agonist indicated in adults for treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
Xtandi (enzalutamide) Capsules
Date of Approval: August 31, 2012
Company: Medivation Inc. and Astellas Pharma Inc.
Treatment for: Prostate Cancer
Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
September 2012
Exelon (rivastigmine)
New Formulation Approved: August 31, 2012
New Formulation Approved: August 31, 2012
Bosulif (bosutinib) Tablets
Date of Approval: September 4, 2012
Company: Pfizer Inc.
Treatment for: Chronic Myelogenous Leukemia
Bosulif (bosutinib) is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML).
Aubagio (teriflunomide) Tablets
Date of Approval: September 12, 2012
Company: Sanofi
Treatment for: Multiple Sclerosis
Aubagio (teriflunomide) is an oral pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.
Prolia (denosumab)
New Indication Approved: September 21, 2012
Stivarga (regorafenib) Tablets
Date of Approval: September 27, 2012
Company: Bayer HealthCare Pharmaceuticals
Treatment for: Colorectal Cancer
Stivarga (regorafenib) is an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer.
Humira (adalimumab)
New Indication Approved: September 28, 2012
Quillivant XR (methylphenidate) for Extended-Release Oral Suspension
Date of Approval: September 27, 2012
Company: NextWave Pharmaceuticals, Inc.
Treatment for: Attention Deficit Disorder
Quillivant XR (methylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
October 2012
Cystaran (cysteamine hydrochloride) Ophthalmic Solution – formerly Cystoran
Date of Approval: October 2, 2012
Company: Sigma-Tau Pharmaceuticals, Inc.
Treatment for: Cystinosis
Cystaran (cysteamine cysteamine ophthalmic solution) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Date of Approval: October 2, 2012
Company: Sigma-Tau Pharmaceuticals, Inc.
Treatment for: Cystinosis
Cystaran (cysteamine cysteamine ophthalmic solution) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Abraxane (paclitaxel protein-bound)
New Indication Approved: October 11, 2012
Jetrea (ocriplasmin) Intravitreal Injection
Date of Approval: October 17, 2012
Company: ThromboGenics NV
Treatment for: Vitreomacular Adhesion
Jetrea (ocriplasmin) is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion
Fycompa (perampanel) Tablets
Date of Approval: October 22, 2012
Company: Eisai Inc.
Treatment for: Epilepsy, Seizures
Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.
Synribo (omacetaxine mepesuccinate) – formerly Omapro
Date of Approval: October 26, 2012
Company: Teva Pharmaceuticals
Treatment for: Chronic Myelogenous Leukemia
Synribo (omacetaxine mepesuccinate) is a first-in-class small molecule drug for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia.
November 2012
Xarelto (rivaroxaban)
New Indication Approved: November 2, 2012
Xeljanz (tofacitinib) Tablets
Date of Approval: November 6, 2012
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis
Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Date of Approval: November 6, 2012
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis
Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Promacta (eltrombopag)
New Indication Approved: November 16, 2012
Flucelvax (influenza virus vaccine)
Date of Approval: November 20, 2012
Company: Novartis
Treatment for: Influenza Prophylaxis
Flucelvax (influenza virus vaccine) is an inactivated vaccine indicated for active immunization for the prevention of influenza
Cometriq (cabozantinib) Capsules
Date of Approval: November 29, 2012
Company: Exelixis, Inc.
Treatment for: Thyroid Cancer
Cometriq (cabozantinib) is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer.
December 2012
Fulyzaq (crofelemer) Delayed-Release Tablets
Company: Salix Pharmaceuticals, Ltd.
Date of Approval: December 31, 2012
Treatment for: Diarrhea
Fulyzaq (crofelemer) is a proanthocyanidin oligomer indicated to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.
Company: Salix Pharmaceuticals, Ltd.
Date of Approval: December 31, 2012
Treatment for: Diarrhea
Fulyzaq (crofelemer) is a proanthocyanidin oligomer indicated to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.
Eliquis (apixaban) Tablets
Company: Bristol-Myers Squibb Company and Pfizer Inc.
Date of Approval: December 28, 2012
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation
Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Sirturo (bedaquiline) Tablets
Company: Janssen Research & Development, LLC
Date of Approval: December 28, 2012
Treatment for: Tuberculosis — Resistant
Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug indicated for the treatment of pulmonary multi-drug resistant tuberculosis.
Adasuve (loxapine) Inhalation Powder – formerly AZ-004
Company: Alexza Pharmaceuticals, Inc.
Date of Approval: December 21, 2012
Treatment for: Agitation, Schizophrenia, Bipolar Disorder
Adasuve (loxapine) is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
Juxtapid (lomitapide) Capsules
Company: Aegerion Pharmaceuticals Inc.
Date of Approval: December 21, 2012
Treatment for: Homozygous Familial Hypercholesterolemia
Juxtapid (lomitapide) is a microsomal triglyceride transfer protein inhibitor indicated for the treatment of patients with homozygous familial hypercholesterolemia.
Gattex (teduglutide) for Injection
Company: NPS Pharmaceuticals, Inc.
Date of Approval: December 21, 2012
Treatment for: Short Bowel Syndrome
Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of adults with short bowel syndrome.
ABthrax (raxibacumab)
Company: GlaxoSmithKline
Date of Approval: December 14, 2012
Treatment for: Inhalation Bacillus anthracis
Raxibacumab is a human monoclonal antibody drug for the treatment of inhalational anthrax.
Flucelvax (influenza virus vaccine)
Company: Novartis
Date of Approval: November 20, 2012
Treatment for: Influenza Prophylaxis
Flucelvax (influenza virus vaccine) is an inactivated vaccine indicated for active immunization for the prevention of influenza.
Xeljanz (tofacitinib) Tablets
Company: Pfizer Inc.
Date of Approval: November 6, 2012
Treatment for: Rheumatoid Arthritis
Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Synribo (omacetaxine mepesuccinate) – formerly Omapro
Company: Teva Pharmaceuticals
Date of Approval: October 26, 2012
Treatment for: Chronic Myelogenous Leukemia
Synribo (omacetaxine mepesuccinate) is a first-in-class small molecule drug for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia.
Fycompa (perampanel) Tablets
Company: Eisai Inc.
Date of Approval: October 22, 2012
Treatment for: Epilepsy, Seizures
Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.
Jetrea (ocriplasmin) Intravitreal Injection
Company: ThromboGenics NV
Date of Approval: October 17, 2012
Treatment for: Vitreomacular Adhesion
Jetrea (ocriplasmin) is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion.
Cystaran (cysteamine hydrochloride) Ophthalmic Solution – formerly Cystoran
Company: Sigma-Tau Pharmaceuticals, Inc.
Date of Approval: October 2, 2012
Treatment for: Cystinosis
Cystaran (cysteamine cysteamine ophthalmic solution) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Stivarga (regorafenib) Tablets
Company: Bayer HealthCare Pharmaceuticals
Date of Approval: September 27, 2012
Treatment for: Colorectal Cancer
Stivarga (regorafenib) is an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer.
THANKS AND REGARD’S
DR ANTHONY MELVIN CRASTO Ph.D
DR ANTHONY MELVIN CRASTO Ph.D
GLENMARK SCIENTIST , NAVIMUMBAI, INDIA
did you feel happy, a head to toe paralysed man’s soul in action for you round the clock
need help, email or call me
MOBILE-+91 9323115463
web link
I was paralysed in dec2007, Posts dedicated to my family, my organisation Glenmark, Your readership keeps me going and brings smiles to my family
No comments:
Post a Comment