New Drug Approvals Archive 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.

• Fluarix GlaxoSmithKline - Treatment for Influenza Vaccination
• Fluarix Quadrivalent (influenza virus vaccine, inactivated) FDA Approval History

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.

• Insys Therapeutics Announces FDA Approval of Subsys Fentanyl Sublingual Spray
• Subsys (fentanyl) FDA Approval History

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.

• FDA Approves Voraxaze to Treat Patients with Toxic Methotrexate Levels
• Voraxaze (glucarpidase) FDA Approval History

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.

• FDA Approves Zetonna (ciclesonide) Nasal Aerosol for Allergic Rhinitis
• Zetonna (ciclesonide) FDA Approval History

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.

• 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
• Picato (ingenol mebutate) FDA Approval History

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.

• FDA Approves Inlyta for Advanced Renal Cell Carcinoma
• Inlyta (axitinib) FDA Approval History

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).

• FDA Approves Erivedge for Basal Cell Carcinoma
• Erivedge (vismodegib) FDA Approval History

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.

• FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis
• Kalydeco (ivacaftor) FDA Approval History

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.

• FDA Approves Jentadueto (linagliptin/metformin hydrochloride) for the Treatment of Adult Patients with Type 2 Diabetes
• Jentadueto (linagliptin and metformin hydrochloride) FDA Approval History

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.

• Sanofi Announces FDA Approval of Sklice Lotion for the Treatment of Head Lice
• Sklice (ivermectin) FDA Approval History

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.

• Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol
• Mitosol (mitomycin) FDA Approval History

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.

• FDA Approves Zioptan (tafluprost ophthalmic solution), Merck's Once-Daily, Preservative-Free Ophthalmic Medication
• Zioptan (tafluprost) FDA Approval History

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.

• BioSante Pharmaceuticals Announces FDA Approval for Male Testosterone Gel
• Testosterone Gel (testosterone) FDA Approval History

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.

• FDA Approves Korlym for Patients with Endogenous Cushing's Syndrome
• Korlym (mifepristone) FDA Approval History

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.

• Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules
• Ultresa (pancrelipase) FDA Approval History

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.

• Aptalis Pharma Announces FDA Approval of Viokace (Pancrelipase) Tablets
• Viokace (pancrelipase) FDA Approval History

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.

• Discovery Labs Announces FDA Approval of Surfaxin (lucinactant) for Prevention of Respiratory Distress Syndrome
• Surfaxin (lucinactant) FDA Approval History

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.

• FDA Approves Binosto, First and Only Effervescent Osteoporosis Treatment in a Buffered Solution
• Binosto (alendronate) FDA Approval History

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).

• Teva Announces FDA Approval of QNASL (beclomethasone dipropionate), a New Nonaqueous Nasal Aerosol, for the Treatment of Allergic Rhinitis
• QNASL (beclomethasone dipropionate) FDA Approval History

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.

• 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
• Omontys (peginesatide) FDA Approval History

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.

• FDA Approves Amyvid (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
• Amyvid (florbetapir F 18) FDA Approval History

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).

• FDA Approves Stendra for Erectile Dysfunction
• Stendra (avanafil) FDA Approval History

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.

• FDA Approves New Orphan Drug Elelyso to Treat a Form of Gaucher Disease
• Elelyso (taliglucerase alfa) FDA Approval History

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.

• MEDA Announces Dymista Approved by the FDA
• Dymista (azelastine and fluticasone) FDA Approval History

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.

• Stiefel Receives US FDA Approval of Fabior Foam, 0.1%
• Fabior (tazarotene) FDA Approval History

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.

• Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules
• Pertzye (pancrelipase) FDA Approval History

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.

• FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
• Perjeta (pertuzumab) FDA Approval History

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).

• GSK Receives FDA Approval for MenHibrix
• MenHibrix (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine) FDA Approval History

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.

• FDA Approves Belviq to Treat Some Overweight or Obese Adults
• Belviq (lorcaserin) FDA Approval History

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.

• FDA Approves Myrbetriq for Overactive Bladder
• Myrbetriq (mirabegron) FDA Approval History

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.

• FDA Approves Prepopik for Colonoscopy Prep
• Prepopik (sodium picosulfate, magnesium oxide and citric acid) FDA Approval History

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.

• FDA Approves Weight-Management Drug Qsymia
• Qsymia (phentermine and topiramate) FDA Approval History

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.

• FDA Approves Kyprolis (carfilzomib) for Patients with Advanced Multiple Myeloma
• Kyprolis (carfilzomib) FDA Approval History

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.

• FDA Approves Tudorza Pressair to Treat Chronic Obstructive Pulmonary Disease
• Tudorza (aclidinium bromide) FDA Approval History

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.

• Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia
• Vascepa (icosapent ethyl) FDA Approval History

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).

• Horizon Pharma Announces FDA Approval of Rayos (prednisone) Delayed-Release Tablets for Rheumatoid Arthritis and Multiple Additional Indications
• Rayos (prednisone) FDA Approval History

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.

• FDA Approves Zaltrap for Metastatic Colorectal Cancer
• Zaltrap (ziv-aflibercept) FDA Approval History

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).

• FDA Approves Marqibo for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
• Marqibo (vincristine sulfate liposomes) FDA Approval History

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.

• Sanofi Announces FDA Approval for Auvi-Q, First Voice-guided Epinephrine Auto-injector for Patients with Life-threatening Allergies
• Auvi-Q (epinephrine) FDA Approval History

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.

• FDA Approves New Combination Pill Stribild for HIV Treatment
• Stribild (cobicistat, elvitegravir, emtricitabine and tenofovir) FDA Approval History

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.

• FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
• Granix (tbo-filgrastim) FDA Approval History

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.

• FDA Approves Linzess to Treat Certain Cases of Irritable Bowel Syndrome and Constipation
• Linzess (linaclotide) FDA Approval History

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.

• FDA Approves Xtandi for Late-Stage Castration-Resistant Prostate Cancer
• Xtandi (enzalutamide) FDA Approval History

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).

• FDA Approves Bosulif for Chronic Myelogenous Leukemia
• Bosulif (bosutinib) FDA Approval History

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.

• FDA Approves New Multiple Sclerosis Treatment Aubagio
• Aubagio (teriflunomide) FDA Approval History

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.

• FDA Approves Stivarga for Advanced Colorectal Cancer
• Stivarga (regorafenib) FDA Approval History

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).

• NextWave Pharmaceuticals Receives FDA Approval of Quillivant XR for Once-Daily Treatment of ADHD
• Quillivant XR (methylphenidate) FDA Approval History

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.

• Sigma-Tau Pharmaceuticals, Inc. Receives FDA Approval of Cystaran (cysteamine ophthalmic solution) 0.44%
• Cystaran (cysteamine hydrochloride) FDA Approval History

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.

• FDA Approves Jetrea for Symptomatic Vitreomacular Adhesion in the Eyes
• Jetrea (ocriplasmin) FDA Approval History

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.

• FDA Approves Fycompa (perampanel) to Treat Partial Onset Seizures
• Fycompa (perampanel) FDA Approval History

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.

• FDA Approves Synribo for Chronic Myelogenous Leukemia
• Synribo (omacetaxine mepesuccinate) FDA Approval History

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.

• FDA Approves Xeljanz for Rheumatoid Arthritis
• Xeljanz (tofacitinib) FDA Approval History

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.

• FDA Approves Cometriq (cabozantinib) to Treat Rare Type of Thyroid Cancer
• Cometriq (cabozantinib) FDA Approval History

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.

• FDA Approves Evarrest Fibrin Sealant Patch
• Evarrest (fibrin sealant) FDA Approval History

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.

• FDA Approves Iclusig to Treat Two Rare Types of Leukemia
• Iclusig (ponatinib) FDA Approval History

(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.

• FDA Approves Raxibacumab to Treat Inhalational Anthrax
• raxibacumab FDA Approval History

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.

• FDA Approves Signifor, a New Orphan Drug for Cushing’s Disease
• Signifor (pasireotide) FDA Approval History

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.

• FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults
• Adasuve (loxapine) FDA Approval History

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.

• FDA Approves Biotest's Bivigam, an Intravenous Immune Globulin (Human), 10% Liquid
• Bivigam (immune globulin intravenous) FDA Approval History

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.

• FDA Approves Gattex to Treat Short Bowel Syndrome
• Gattex (teduglutide) FDA Approval History

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.

• FDA Approves Varizig for Reducing Chickenpox Symptoms
• VariZIG (varicella zoster immune globulin) FDA Approval History

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.

• FDA Approves Juxtapid - New Orphan Drug for Rare Cholesterol Disorder
• Juxtapid (lomitapide) FDA Approval History

Eliquis (apixaban) Tablets and Tablets for Oral Suspension

Date of Approval: December 28, 2012
Company: Bristol-Myers Squibb Company
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Deep Vein Thrombosis, Deep Vein Thrombosis, Prophylaxis, Pulmonary Embolism, Thromboembolic Stroke Prophylaxis, Venous Thromboembolism

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 treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial therapy.

• FDA Approves Eliquis to Reduce the Risk of Stroke, Blood Clots in Patients with Non-Valvular Atrial Fibrillation
• Eliquis (apixaban) FDA Approval History

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.

• FDA Grants Accelerated Approval for Sirturo to Treat Multi-Drug Resistant Tuberculosis
• Sirturo (bedaquiline) FDA Approval History

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.

• FDA Approves Fulyzaq - First Anti-Diarrheal Drug for HIV/AIDS Patients
• Mytesi (crofelemer) FDA Approval History