New Drug Approvals Archive
New Drug Approvals: July 2009
| July 1 | Multaq (dronedarone) Tablets Date of Approval: July 1, 2009 Company: Sanofi-aventis Treatment for: Atrial Fibrillation, Atrial Flutter Multaq (dronedarone) is antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with atrial fibrillation or atrial flutter. FDA Approves Multaq for Patients with Atrial Fibrillation or Atrial Flutter |
| July 7 | Alimta (pemetrexed)
New Indication Approved: July 2, 2009 Lilly Receives Fourth FDA Approval for Alimta (pemetrexed for injection) as Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer |
| July 10 | Effient (prasugrel) Tablets Date of Approval: July 10, 2009 Company: Daiichi Sankyo Company, Limited and Eli Lilly and Company Treatment for: Acute Coronary Syndrome Effient (prasugrel) is an oral antiplatelet agent for the treatment of patients with acute coronary syndrome (ACS) who are managed with percutaneous coronary intervention including coronary stenting. Daiichi Sankyo and Lilly Receive U.S. FDA Approval for Effient |
| July 10 | Plan B One-Step (levonorgestrel) Tablet Date of Approval: July 10, 2009 Company: Teva Pharmaceuticals, Inc. Treatment for: Emergency Contraception Plan B One-Step (levonorgestrel) is a single dose emergency contraceptive pill to help prevent an unintended pregnancy after unprotected sex or contraceptive failure. Plan B One-Step will be available over-the-counter (OTC) for consumers age 17 or older; women younger than age 17 will require a prescription. FDA Approves Plan B One-Step, a New One-Pill Emergency Contraceptive |
| July 15 | Sumavel DosePro (sumatriptan) Injection Date of Approval: July 15, 2009 Company: Zogenix, Inc. Treatment for: Migraine, Cluster Headache Sumavel DosePro (sumatriptan injection) is a needle-free delivery system to treat acute migraine, with or without aura, and cluster headache. Sumavel DosePro (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System |
| July 16 | 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. BioDelivery Sciences and Meda Announce FDA Approval of Onsolis |
| July 20 | NovoLog (insulin aspart)
Expiration Date Change Approved: July 14, 2009 FDA Approves NovoLog Labeling Update |
| July 21 | Tekturna HCT (aliskiren and hydrochlorothiazide)
New Indication Approved: July 16, 2009 FDA Approves Tekturna HCT as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent |
| July 22 | 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. Allergan Receives FDA Approval for Acuvail Ophthalmic Solution for the Treatment of Pain and Inflammation Following Cataract Surgery |
| July 23 | Forteo (teriparatide (rDNA origin))
New Indication Approved: July 22, 2009 FDA Approves Expanded Use of Lilly's Forteo [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis |
| July 29 | Sculptra (injectable poly-L-lactic acid)
New Formulation Approved: July 29, 2009 Treatment for: Facial Lipoatrophy; Facial Wrinkles FDA Approves Sculptra Aesthetic, a Facial Injectable for Correction of Nasolabial Folds and Other Facial Wrinkles |
| July 30 | 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. FDA Approves Tyvaso (treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension |
| July 29 | Colcrys (colchicine) Tablets Date of Approval: July 29, 2009 Company: Mutual Pharmaceutical Company, Inc. Treatment for: Gout, Familial Mediterranean Fever, Gout -- Prophylaxis, Acute Gout Colcrys (colchicine) is compound derived from the dried seeds of the autumn crocus or meadow saffron (Colchicum autumnale). Colcrys is approved for the prophylaxis and treatment of acute gout flares, and for the treatment of patients with familial Mediterranean fever. FDA Approves Colcrys (colchicine) for Acute Gout, Mediterranean Fever |
| July 31 | 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. FDA Approves Onglyza (saxagliptin) for Type 2 Diabetes |
| July 31 | 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. The US FDA approves Lipsovir for marketing and sales in US |
| October 22 | Colcrys (colchicine)
New Indication Approved: October 16, 2009 FDA Approves Colcrys (colchicine, USP) for Prevention of Gout Flares |
New Drug Approvals Archive
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