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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: Diabetes, Type 2

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 Associated with Chronic Renal Failure

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 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).

Belviq (lorcaserin) Tablets

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 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: Obesity

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 indicated 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: Allergan, 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 and Tablets

Date of Approval: August 31, 2012
Company: Astellas Pharma Inc.
Treatment for: Prostate Cancer

Xtandi (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer.

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.

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: Ariad Pharmaceuticals, Inc.
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia

Iclusig (ponatinib) is a kinase inhibitor indicated for the treatment of adult patients with:
  • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
  • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.
  • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

(raxibacumab)

Date of Approval: December 14, 2012
Company: Emergent BioSolutions, Inc.
Treatment for: Anthrax

Raxibacumab is a human monoclonal antibody drug for the treatment of inhalational anthrax.

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 indicated 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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