New Drug Applications Archive - September 2009
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September 1, 2009
- Pozen Announces FDA Acceptance of NDA For Vimovo
- Photocure ASA (NO) - Hexvix has been granted priority review by the FDA
September 2, 2009
- Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin
- Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
- FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma
September 3, 2009
- FDA accepts for review the Complete Response submission to ceftobiprole NDA
- Endo Pharmaceuticals Gives Update on Regulatory Status of Testosterone Undecanoate for Men with Hypogonadism
- Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of Folotyn (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
- Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application
- Acura Pharmaceuticals and King Pharmaceuticals Provide Update on Acurox NDA
September 4, 2009
September 6, 2009
September 7, 2009
September 9, 2009
- ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA
- FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine
September 10, 2009
- FDA Advisory Committee Recommends Approval for Use of Gardasil ln Boys and Men
- FDA Issues Complete Response Letter For Trabectedin Combined With Doxil
September 11, 2009
- Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA
- Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval
September 17, 2009
- FDA Advisory Committee Unanimously Recommends Approval of Xiaflex for Treatment of Dupuytren's Disease
- Sanofi-Aventis Receives Complete Response Letter from the FDA for eplivanserin (Ciltyri) Submission
