New Drug Approvals Archive
New Drug Approvals: March 2009
| March 3 | Copaxone Approved by the FDA for Patients with a First Clinical Event Suggestive of Multiple Sclerosis |
| March 5 | Temodar (temozolomide)
New Dosage Form Approved: February 27, 2009 United States Food and Drug Administration (FDA) Approves IV Formulation of Temodar (temozolomide) |
| March 13 | Edluar (zolpidem) Sublingual Tablets - formerly Sublinox Date of Approval: March 13, 2009 Company: Orexo and Meda AB Treatment for: Insomnia Edluar (formerly Sublinox) is a fast-acting sublingual tablet formulation of the widely used drug zolpidem. Edluar is approved for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Orexo's Edluar (formerly Sublinox) receives FDA approval for the treatment of insomnia |
| March 20 | Lexapro (escitalopram oxalate)
Patient Population Altered: March 20, 2009 Forest Laboratories, Inc. Announces FDA Approval of Lexapro for the Treatment of Major Depressive Disorder in Adolescents |
| March 23 | Symbyax (fluoxetine and olanzapine)
New Indication Approved: March 19, 2009 FDA Approves Symbyax as First Medication for Treatment-Resistant Depression |
| March 24 | Tygacil (tigecycline)
New Indication Approved: March 20, 2009 FDA Approves New Indication for Wyeth's Tygacil (tigecycline) for the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia |
| March 30 | Afinitor (everolimus) Tablets Date of Approval: March 30, 2009 Company: Novartis AG Treatment for: Renal Cell Carcinoma Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. Afinitor approved in US as first treatment for patients with advanced kidney cancer after failure of either sunitinib or sorafenib |
| March 30 | Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) Date of Approval: March 30, 2009 Company: Intercell AG Treatment for: Japanese Encephalitis Virus Prophylaxis Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed) is a purified, inactivated product for active immunization against viral infections of Japanese Encephalitis. Intercell Announces FDA Approval of Ixiaro, a Novel Vaccine to Prevent Japanese Encephalitis |
New Drug Approvals Archive
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