Latest New Drug Approvals
Valturna (aliskiren and valsartan) Tablets
Date of Approval: September 17, 2009
Company: Novartis
Treatment for: Hypertension
Valturna is a combination of aliskiren (a direct renin inhibitor) and valsartan (an angiotensin II receptor blocker) indicated for the treatment of high blood pressure.
Influenza A (H1N1) 2009 Monovalent Vaccine
Date of Approval: September 15, 2009
Company: CSL Limited; Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc.; MedImmune LLC
Treatment for: Influenza Prophylaxis
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
Zirgan (ganciclovir) Ophthalmic Gel
Date of Approval: September 15, 2009
Company: Sirion Therapeutics, Inc.
Treatment for: Keratitis
Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).
Vibativ (telavancin) Injection
Date of Approval: September 11, 2009
Company: Theravance Inc.
Treatment for: Skin and Structure Infection
Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.
Bepreve (bepotastine) Ophthalmic Solution
Date of Approval: September 8, 2009
Company: ISTA Pharmaceuticals, Inc.
Treatment for: Allergic Conjunctivitis
Bepreve (bepotastine ophthalmic solution) is an antihistamine and mast cell stabilizer for treatment of the symptoms of allergic conjunctivitis.
Metozolv ODT (metoclopramide) Orally Disintegrating Tablets
Date of Approval: September 4, 2009
Company: Salix Pharmaceuticals, Ltd.
Treatment for: Gastroesophageal Reflux Disease, Gastroparesis
Metozolv ODT is a fast–dissolving formulation of metoclopramide for the short–term treatment of adults with gastroesophageal reflux and for the relief of symptoms associated with diabetic gastroparesis.
Intuniv (guanfacine) Extended Release Tablets – formerly Connexyn
Date of Approval: September 2, 2009
Company: Shire plc
Treatment for: Attention Deficit Disorder
Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Zenpep (pancrelipase) Capsules – formerly Zentase
Date of Approval: August 27, 2009
Company: Eurand Pharmaceuticals Ltd.
Treatment for: Pancreatic Exocrine Dysfunction
Zenpep (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.
Sabril (vigabatrin) Tablets and Oral Solution
Date of Approval: August 21, 2009
Company: Lundbeck Inc.
Treatment for: Epilepsy, Seizures
Sabril (vigabatrin) is an oral irreversible GABA-transaminase inhibitor for the treatment of Infantile Spasms and refractory complex partial seizures.
Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)) Solution for Intramuscular Injection
Date of Approval: August 19, 2009
Company: GlaxoSmithKline
Treatment for: Haemophilus influenzae Prophylaxis
Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children 15 months through 4 years of age (prior to fifth birthday).
Extavia (interferon beta-1b)
Date of Approval: August 14, 2009
Treatment for: Multiple Sclerosis
Extavia is a branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for multiple sclerosis for many years. Extavia is indicated for the treatment of MS patients with relapsing forms of the disease and for newly diagnosed patients.
Saphris (asenapine) Sublingual Tablets
Date of Approval: August 13, 2009
Company: Schering-Plough Corporation
Treatment for: Schizophrenia, Bipolar Disorder
Saphris (asenapine) is an atypical antipsychotic for the treatment of schizophrenia and acute mania or mixed episodes associated with bipolar I disorder.
Embeda (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules
Date of Approval: August 13, 2009
Company: King Pharmaceuticals , Inc.
Treatment for: Pain
Embeda is an abuse-deterrent, extended-release morphine preparation for the treatment of chronic pain.
Livalo (pitavastatin) Tablets
Date of Approval: August 3, 2009
Company: Kowa Company, Ltd.
Treatment for: High Cholesterol
Livalo (pitavastatin) is an HMG CoA reductase inhibitor indicated for the primary treatment of hypercholesterolemia and combined dyslipidemia.
Lipsovir (acyclovir and hydrocortisone) Topical Cream
Date of Approval: July 31, 2009
Company: Medivir
Treatment for: Herpes Simplex Labialis
Lipsovir is topical combination of hydrocortisone (an anti-inflammatory agent) and acyclovir (an antiviral agent) for the prevention and treatment of cold sores.
Onglyza (saxagliptin) Tablets
Date of Approval: July 31, 2009
Company: Bristol-Myers Squibb Company and AstraZeneca
Treatment for: Diabetes Mellitus Type II
Onglyza (saxagliptin) is a dipeptidyl peptidase-4 (DPP4) inhibitor indicated for the treatment of type 2 diabetes mellitus in adults.
Colcrys (colchicine) Tablets
Date of Approval: July 29, 2009
Company: Mutual Pharmaceutical Company, Inc.
Treatment for: Gout, Familial Mediterranean Fever
Colcrys (colchicine) is compound derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale). Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. Colcrys is approved to treat acute flairs in patients with gout, and patients with familial Mediterranean fever.
Tyvaso (treprostinil) Inhalation Solution
Date of Approval: July 30, 2009
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension
Tyvaso (treprostinil) is an inhaled prostanoid analogue indicated for the treatment of pulmonary arterial hypertension.
Acuvail (ketorolac tromethamine) Ophthalmic Solution
Date of Approval: July 22, 2009
Company: Allergan, Inc.
Treatment for: Postoperative Ocular Inflammation
Acuvail (ketorolac tromethamine) is a preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.
Onsolis (fentanyl) Buccal Soluble Film – formerly BEMA Fentanyl
Date of Approval: July 16, 2009
Company: BioDelivery Sciences International, Inc.
Treatment for: Pain
Onsolis consists of a dissolvable polymer film formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek). Onsolis is used for the management of breakthrough pain in patients with cancer.
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