New Drug Approvals Archive
New Drug Approvals: August 2007
| 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 14 | Ranexa (ranolazine)
New Formulation Approved: August 14, 2007 CV Therapeutics Launches 1000 mg Ranexa Tablet |
| August 16 | Zingo (lidocaine hydrochloride monohydrate) Dermal PowderJect Date of Approval: August 16, 2007 Company: Anesiva, Inc. Treatment for: Local Anesthesia Zingo (lidocaine hydrochloride monohydrate) 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. 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 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 27 | 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 30 | 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 |
| August 31 | ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) Date of Approval: August 31, 2007 Company: Acambis Inc. Treatment for: Smallpox Prophylaxis ACAM2000 is live vaccinia virus smallpox vaccine intended for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 is the first biodefense vaccine to be approved as part of the US response to the 2001 bioterrorism attacks. FDA Approves ACAM2000 Vaccine for Protection Against Smallpox |
| January 9 | Zingo (lidocaine hydrochloride monohydrate)
Patient Population Altered: January 8, 2009 Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults |
New Drug Approvals Archive
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