New Drug Approvals Archive
New Drug Approvals: September 2009
| September 2 | Astepro (azelastine)
New Formulation Approved: August 31, 2009 Meda Receives FDA Approval of New Astepro (azelastine HCl) Nasal Spray 0.15%, the First and Only Once-Daily Nasal Antihistamine |
| September 2 | Intuniv (guanfacine) Extended Release Tablets - formerly Connexyn Date of Approval: September 2, 2009 Company: Shire plc Treatment for: Attention-Deficit Hyperactivity Disorder Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17 |
| September 4 | Zevalin (ibritumomab tiuxetan)
New Indication Approved: September 3, 2009 FDA Approves Zevalin Expanded Label as Part of First-Line Therapy in Treatment of Follicular Non-Hodgkin's Lymphoma |
| September 4 | 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. Salix Receives FDA Marketing Approval for Metozolv ODT (Orally Disintegrating Tablets) for Relief of Diabetic Gastroparesis and Symptomatic Documented GERD |
| September 8 | 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. Ista Pharmaceuticals' Bepreve Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies |
| September 11 | Vibativ (telavancin) Injection Date of Approval: September 11, 2009 Company: Theravance Inc. Treatment for: Complicated Skin and Skin Structure Infections (cSSSI) 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. Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections |
| September 15 | Zirgan (ganciclovir) Ophthalmic Gel Date of Approval: September 15, 2009 Company: Sirion Therapeutics, Inc. Treatment for: Herpetic Keratitis Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers). Sirion Therapeutics Announces FDA Approval of Zirgan (ganciclovir ophthalmic gel) 0.15% for Herpetic Keratitis |
| September 15 | Date of Approval: September 15, 2009 Company: CSL Limited; Novartis Vaccines and Diagnostics Limited; Sanofi Pasteur, Inc.; MedImmune LLC Treatment for: Prevention of H1N1 Influenza Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. FDA Approves Vaccines for 2009 H1N1 Influenza Virus |
| September 16 | Valturna (aliskiren and valsartan) Tablets Date of Approval: September 16, 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. Novartis receives FDA approval for Valturna, a single-pill combination of valsartan and aliskiren, to treat high blood pressure |
| September 24 | Folotyn (pralatrexate) Injection Date of Approval: September 24, 2009 Company: Allos Therapeutics, Inc. Treatment for: Peripheral T-cell Lymphoma Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma |
| September 25 | Stelara (ustekinumab) Injection Date of Approval: September 25, 2009 Company: Centocor Ortho Biotech Inc. Treatment for: Psoriasis Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis. FDA Approves Stelara (ustekinumab) to Treat Psoriasis |
| November 13 |
Patient Population Altered: November 10, 2009 Treatment for: Prevention of H1N1 Influenza FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children |
New Drug Approvals Archive
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