New Drug Approvals Archive
New Drug Approvals: August 2007
| August 6 | Indevus Announces FDA Approval of Sanctura XR |
| August 6 | FDA Approves New Dosage Strength Of Stalevo |
| August 6 | Selzentry (maraviroc) Tablets Date of Approval: August 6, 2007 Company: Pfizer Inc. Treatment for HIV Infection Selzentry (maraviroc) is the first in a class of drugs known as CCR5 antagonists, approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood (viral load). Pfizer's Selzentry (Maraviroc) Tablets, Novel Treatment for HIV, Approved by FDA |
| August 7 | Abraxis BioScience Receives FDA Approval for Oxytocin Injection 10 USP Units/mL in a 30 mL Vial |
| August 7 | Health Canada Approves Sativex for Cancer Pain |
| August 10 | FDA Grants Additional Six Months Marketing Exclusivity for the High Blood Pressure Medicine Diovan |
| August 13 | LifeCycle Pharma and Sciele Pharma Announce FDA Approval of New Formulation of Fenofibrate in 120 mg. and 40 mg. Dosage Strengths |
| August 14 | Ranexa (ranolazine)
New Formulation Approved: August 14, 2007 CV Therapeutics Launches 1000 mg Ranexa Tablet |
| August 17 | Zingo (lidocaine hydrochloride monohydrate) Dermal PowderJect Date of Approval: August 16, 2007 Company: Anesiva, Inc. Treatment for Local Anesthesia Zingo is a needle-free, local anesthetic intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children three to 18 years of age. Anesiva Receives FDA Approval for Zingo, a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children |
| August 20 | Reclast (zoledronic acid)
New Indication Approved: August 17, 2007 Reclast Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis |
| August 20 | Duplex For Use with Cefotetan Approved by U.S. Food and Drug Administration |
| August 22 | Risperdal (risperidone)
Patient Population Altered: August 22, 2007 FDA Approves Risperdal to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania |
| August 23 | APA Comments on FDA's First Approval of Medication to Treat Pediatric Schizophrenia and Bipolar Disorder |
| August 28 | Evithrom (human thrombin) Date of Approval: August 27, 2007 Company: Omrix Biopharmaceuticals, Ltd, Treatment for Bleeding Evithrom is a highly purified human thrombin used as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. FDA Approves Evithrom (human thrombin) for Topical Use in Surgery |
| August 31 | Somatuline Depot (lanreotide acetate) Injection - formerly Somatuline Autogel Date of Approval: August 30, 2007 Company: Tercica, Inc. Treatment for Acromegaly Somatuline Depot is a sustained-release injection formulation of lanreotide, a somatostatin analogue indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Ipsen: Somatuline Depot Receives Marketing Approval in the United States for the Treatment of Acromegaly |
New Drug Approvals Archive
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2003: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2002: Oct | Dec
