New Drug Applications Archive - February 2011
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February 1, 2011
- Discovery Labs Provides Expanded Update Regarding Its Program for Surfaxin U.S. Marketing Authorization
- FDA Issues Complete Response to New Drug Application for Contrave for the Management of Obesity
February 4, 2011
- US FDA Assigns New PDUFA Date for Brilinta (ticagrelor tablets)
- Obesity Society Disappointed by FDA Delay on Approval of Obesity Drug
February 24, 2011
February 25, 2011
February 28, 2011
- Shire Files Complete Response to FDA's Not Approvable Letter for Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
- Santarus and Pharming Announce Receipt of FDA Refusal to File Letter for Rhucin Biologics License Application
- Seattle Genetics Submits BLA to FDA for Brentuximab Vedotin in Relapsed or Refractory Hodgkin Lymphoma and Systemic ALCL
