New Drug Applications Archive

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September 2009

September 1

Pozen Announces FDA Acceptance of NDA For Vimovo 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 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

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

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 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 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 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 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

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