New Drug Approvals Archive for 2012
See also: New Indications and Dosage Forms for 2012
Fluarix Quadrivalent (influenza virus vaccine, inactivated) Injection
Date of Approval: December 14, 2012
Company: GlaxoSmithKline
Treatment for: Influenza Prophylaxis
Fluarix Quadrivalent is an inactivated influenza virus vaccine indicated for the prevention of influenza disease in people aged 6 months and older.
Subsys (fentanyl) Sublingual 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.
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.
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.
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.
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 and Oral Granules
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 ages 4 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor.
Jentadueto (linagliptin and metformin hydrochloride) Tablets
Date of Approval: January 30, 2012
Company: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly
Treatment for: Type 2 Diabetes
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.
Sklice (ivermectin) Lotion
Date of Approval: February 7, 2012
Company: Arbor Pharmaceuticals, LLC
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
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.
Testosterone Gel (testosterone) Topical Gel - formerly Bio-T-Gel
Date of Approval: February 14, 2012
Company: ANI Pharmaceuticals, Inc.
Treatment for: Hypogonadism, Male
Testosterone gel 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.
Ultresa (pancrelipase) Delayed Release Capsules
Date of Approval: March 1, 2012
Company: Allergan, Inc.
Treatment for: Pancreatic Exocrine Dysfunction
Marketing Status: Discontinued
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: Allergan, 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
Marketing Status: Discontinued
Surfaxin (lucinactant) is a synthetic, peptide-containing surfactant indicated for the prevention of respiratory distress syndrome (RDS) in premature infants.
Binosto (alendronate) Effervescent Tablets
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
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).
Omontys (peginesatide) Injection
Date of Approval: March 27, 2012
Company: Affymax, Inc. and Takeda Pharmaceutical Company Limited
Treatment for: Anemia Due to Chronic Kidney Disease
Marketing Status: Discontinued
Omontys (peginesatide) an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
Amyvid (florbetapir F 18) Injection
Date of Approval: April 6, 2012
Company: Eli Lilly and Company and Avid Radiopharmaceuticals, Inc.
Treatment for: Diagnosis and Investigation
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.
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).
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.
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.
Perjeta (pertuzumab) Injection
Date of Approval: June 8, 2012
Company: Genentech
Treatment for: Breast cancer
Perjeta (pertuzumab) is a humanized monoclonal antibody indicated for the treatment of HER2-positive 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 Disease 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).
Belviq (lorcaserin) Tablets
Date of Approval: June 27, 2012
Company: Arena Pharmaceuticals, Inc.
Treatment for: Weight Loss (Obesity/Overweight)
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 and Granules
Date of Approval: June 28, 2012
Company: Astellas Pharma Inc.
Treatment for: Overactive Bladder; Neurogenic Detrusor Overactivity
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, and neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more.
Myrbetriq Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older.
Prepopik (sodium picosulfate, magnesium oxide and citric acid) for Oral Solution
Date of Approval: July 16, 2012
Company: Ferring Pharmaceuticals
Treatment for: Bowel Preparation
Marketing Status: Discontinued
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: Weight Loss (Obesity/Overweight)
Qsymia (phentermine and topiramate) is a sympathomimetic amine anorectic and anticonvulsant combination for use in chronic weight management.
Kyprolis (carfilzomib) Injection
Date of Approval: July 20, 2012
Company: Amgen Inc.
Treatment for: Multiple Myeloma
Kyprolis (carfilzomib) is a proteasome inhibitor used for the treatment of patients with multiple myeloma.
Tudorza (aclidinium bromide) Pressair
Date of Approval: July 23, 2012
Company: Allergan, Inc.
Treatment for: COPD
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, Cardiovascular Risk Reduction
Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and as an adjunct to statin therapy to reduce the risk of of cardiovascular events.
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, COPD
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).
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.
Marqibo (vincristine sulfate liposomes) Injection - formerly Onco TCS
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).
Auvi-Q (epinephrine) Injection
Date of Approval: August 10, 2012
Company: Sanofi
Treatment for: Anaphylaxis, Allergic Reactions
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.
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.
Granix (tbo-filgrastim) Injection
Date of Approval: August 29, 2012
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Neutropenia Associated with Chemotherapy
Granix (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: AbbVie Inc.
Treatment for: Irritable Bowel Syndrome with Constipation, Chronic Idiopathic Constipation, Functional Constipation
Linzess (linaclotide) is a guanylate cyclase-C agonist used for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients 6 to 17 years of age.
Xtandi (enzalutamide) Capsules and Tablets
Date of Approval: August 31, 2012
Company: Astellas Pharma Inc.
Treatment for: Prostate Cancer
Xtandi (enzalutamide) is an androgen receptor inhibitor used for the treatment of prostate cancer.
Bosulif (bosutinib) Tablets and Capsules
Date of Approval: September 4, 2012
Company: Pfizer Inc.
Treatment for: Chronic Myelogenous Leukemia
Bosulif (bosutinib) is a kinase inhibitor for use in the treatment of 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.
Stivarga (regorafenib) Tablets
Date of Approval: September 27, 2012
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Colorectal Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma
Stivarga (regorafenib) is an oral multi-kinase inhibitor for the treatment of patients with metastatic colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma.
Quillivant XR (methylphenidate) for Extended-Release Oral Suspension
Date of Approval: September 27, 2012
Company: NextWave Pharmaceuticals, Inc.
Treatment for: ADHD
Quillivant XR (methylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Cystaran (cysteamine hydrochloride) Ophthalmic Solution
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.
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 and Oral Suspension
Date of Approval: October 22, 2012
Company: Eisai Inc.
Treatment for: Epilepsy, Seizures
Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist indicated for the treatment of partial-onset seizures, and as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy.
Synribo (omacetaxine mepesuccinate)
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.
Xeljanz (tofacitinib) Tablets and Oral Solution
Date of Approval: November 6, 2012
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis
Xeljanz (tofacitinib) is an oral Janus kinase (JAK) inhibitor used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
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.
Evarrest (fibrin sealant) Patch
Date of Approval: December 5, 2012
Company: Ethicon, Inc.
Treatment for: Bleeding Disorder
Evarrest (fibrin sealant patch) is indicated for use with manual compression as an adjunct to hemostasis for problematic soft tissue bleeding during surgery.
Iclusig (ponatinib) Tablets
Date of Approval: December 14, 2012
Company: Takeda
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia
Iclusig (ponatinib) is a kinase inhibitor used for the treatment of acute lymphoblastic leukemia and chronic myeloid leukemia.
Signifor (pasireotide) Injection
Date of Approval: December 14, 2012
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cushing's Syndrome
Signifor (pasireotide) is a multireceptor targeting somatostatin analog for the treatment of patients with Cushing's disease.
Adasuve (loxapine) Inhalation Powder - formerly AZ-004
Date of Approval: December 21, 2012
Company: Alexza Pharmaceuticals, Inc.
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.
Bivigam (immune globulin intravenous) Infusion
Date of Approval: December 21, 2012
Company: Biotest Pharmaceuticals Corporation
Treatment for: Primary Immunodeficiency Syndrome
Bivigam is an immune globulin intravenous (human) indicated for the treatment of primary humoral immunodeficiency.
Gattex (teduglutide) for Injection
Date of Approval: December 21, 2012
Company: NPS Pharmaceuticals, Inc.
Treatment for: Short Bowel Syndrome
Gattex (teduglutide) is a recombinant analog of human glucagon-like peptide 2 for the treatment of short bowel syndrome in adults and pediatric patients one year of age and older.
VariZIG (varicella zoster immune globulin) for Injection
Date of Approval: December 20, 2012
Company: Cangene Corporation
Treatment for: Varicella-Zoster
VariZIG is a varicella zoster immune globulin (human) intended to reduce the severity of chickenpox (varicella) infections in high risk individuals.
Juxtapid (lomitapide) Capsules
Date of Approval: December 21, 2012
Company: Aegerion Pharmaceuticals Inc.
Treatment for: High Cholesterol, Familial Homozygous
Juxtapid (lomitapide) is a microsomal triglyceride transfer protein inhibitor indicated for the treatment of patients with homozygous familial hypercholesterolemia.
Eliquis (apixaban) Tablets
Date of Approval: December 28, 2012
Company: Bristol-Myers Squibb Company and Pfizer Inc.
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery
Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery.
Sirturo (bedaquiline) Tablets
Date of Approval: December 28, 2012
Company: Janssen Research & Development, LLC
Treatment for: Tuberculosis, Resistant
Sirturo (bedaquiline) is an oral diarylquinoline antimycobacterial drug for the treatment of pulmonary multi-drug resistant tuberculosis.
Mytesi (crofelemer) Delayed-Release Tablets - formerly Fulyzaq
Date of Approval: December 31, 2012
Company: Napo Pharmaceuticals, Inc.
Treatment for: Diarrhea
Mytesi (crofelemer) is a proanthocyanidin oligomer indicated to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy.
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