New Drug Applications Archive - August 2009
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August 4, 2009
- Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa
- Kamada's Biologics License Application for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US Food and Drug Administration
August 5, 2009
August 6, 2009
- Abstral NDA submitted to the FDA for approval in the USA
- NeurogesX Announces New PDUFA Date for Qutenza New Drug Application
- Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza (Cethromycin) in Community Acquired Pneumonia
- Opaxio Combined with Alimta Well Tolerated in Dose-Ranging Study of Patients with Advanced Non-Small Cell Lung Cancer
August 7, 2009
August 11, 2009
August 12, 2009
- Vion Pharmaceuticals Announces Oncologic Drugs Advisory Committee Meeting for Onrigin
- Wyeth Provides Regulatory Update on Prevnar 13 in the United States
- Additional Clinical Trial to be Conducted for Kynapid Under FDA Special Protocol Agreement
- U.S. Food And Drug Administration Has Accepted To File Theratechnologies' New Drug Application for tesamorelin
August 14, 2009
August 17, 2009
August 18, 2009
August 19, 2009
August 25, 2009
- Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS
- FDA Issues Complete Response Letter for Carisbamate
- Salix Pharmaceuticals Announces FDA Acceptance for Filing and Priority Review Designation For Rifaximin NDA For the Maintenance of Remission of Hepatic Encephalopathy
August 26, 2009
- Endo Pharmaceuticals to Partner With ProStrakan to Commercialize Fortesta in the U.S.
- FDA Accepts to File Cell Therapeutics' New Drug Application for Pixantrone
