New Drug Applications Archive

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May 2007

May 1

Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol

May 4

ISTA Provides Regulatory Update on T-Pred NDA Filing

May 7

MGI Pharma and Helsinn Announce Submission of Supplemental New Drug Application for Aloxi Injection in Post-Operative Nausea and Vomiting Abbott Seeks U.S. and E.U. Regulatory Approvals for Humira (Adalimumab) as a Treatment for Juvenile Rheumatoid Arthritis

May 8

Fabre-Kramer Refiles Gepirone ER with the FDA for the Treatment of Major Depressive Disorder

May 9

Dendreon Receives Complete Response Letter From FDA for Provenge Biologics License Application Somaxon Pharmaceuticals Provides Update on Silenor Development Program FDA Advisory Committee Reviews Data on IDM Pharma's Junovan (mifamurtide) for Treatment of Osteosarcoma

May 14

Merck Receives Approvable Letter from FDA for Emend (fosaprepitant dimeglumine) For Injection Luitpold Pharmaceuticals, Inc., Announces NDA Submission for Injectafer (Ferric Carboxymaltose Injection), a Next Generation Intravenous Iron Product Questcor Receives FDA Action Letter for H.P. Acthar Gel for Treatment of Infantile Spasms

May 15

Spectrum Pharmaceuticals Announces FDA'S Oncology Drug Advisory Committee to Review Satraplatin for the Treatment of Hormone Refractory Prostate Cancer

May 16

New Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers FDA Advisory Committee Recommends Expanded Use of FluMist

May 18

FDA Advisory Committee Unanimously Votes in Favor of Acambis' Smallpox Vaccine New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole

May 21

Roche Receives Approvable Letter for Mircera in the United States FDA Issues Approvable Letter for SPD465 (Triple-Bead Mixed Amphetamine Salts) for the Treatment of ADHD in Adults Single-Tablet Combination of Tekturna and Diuretic, an Important New Option for People With High Blood Pressure, Accepted for Review in U.S.

May 22

Advancis Pharmaceutical Announces FDA Acceptance of Amoxicillin PULSYS NDA

May 24

BioMarin Submits New Drug Application for U.S. Marketing Authorization of Kuvan for Phenylketonuria (PKU)

May 29

MedImmune Receives Correspondence From FDA Regarding FluMist QLT USA, Inc. files Aczone labeling supplement for removal of blood screening requirement

May 30

Banner Pharmacaps Inc. and JDS Pharmaceuticals LLC Announce License and Supply Agreement

May 31

Progenics and Wyeth Announce FDA Has Accepted For Filing the New Drug Application for Subcutaneous Methylnaltrexone Dendreon Announces FDA Confirms Data Required for Provenge Licensure TopoTarget elaborates on the specific initiatives to obtain FDA approval of Totect

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