New Drug Applications Archive

New Drug Applications: September 2009

September 1	Pozen Announces FDA Acceptance of NDA For Vimovo
September 1	Photocure ASA (NO) - Hexvix has been granted priority review by the FDA
September 2	Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin
September 2	Shire Completes Submission of NDA for Velaglucerase Alfa for Type 1 Gaucher Disease and Reports Positive Results for Remaining Two Phase III Trials
September 2	FDA Advisory Committee Recommends Gloucester Pharmaceuticals' Romidepsin for Approval for Cutaneous T-cell Lymphoma
September 3	FDA accepts for review the Complete Response submission to ceftobiprole NDA
September 3	Endo Pharmaceuticals Gives Update on Regulatory Status of Testosterone Undecanoate for Men with Hypogonadism
September 3	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
September 3	Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application
September 3	Acura Pharmaceuticals and King Pharmaceuticals Provide Update on Acurox NDA
September 4	Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and Actos (pioglitazone HCl) for the Treatment of Type 2 Diabetes
September 6	FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
September 7	Archimedes Announces US Filing of NasalFent for the treatment of Breakthrough Cancer Pain
September 9	ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA
September 9	FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine
September 10	FDA Advisory Committee Recommends Approval for Use of Gardasil ln Boys and Men
September 10	FDA Issues Complete Response Letter For Trabectedin Combined With Doxil
September 11	Merz Pharmaceuticals' Belotero Balance PMA Filing Formally Accepted for Review by the FDA
September 11	Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for Surfaxin Approval
September 17	FDA Advisory Committee Unanimously Recommends Approval of Xiaflex for Treatment of Dupuytren's Disease
September 17	Sanofi-Aventis Receives Complete Response Letter from the FDA for eplivanserin (Ciltyri) Submission
September 18	FDA Grants Priority Review Status to Supplement Containing Long-Term Survival Data for Velcade (bortezomib) for Injection
September 19	Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa
September 23	FDA Advisory Committee Hears Presentations and Public Comment on Exalgo Extended-Release Tablets
September 25	NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA
September 28	GSK Provides Update on Regulatory Filings for Zunrisa/Rezonic
September 29	Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients

New Drug Applications Archive

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