New Drug Applications: 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
May 7	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
May 9	Somaxon Pharmaceuticals Provides Update on Silenor Development Program
May 9	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
May 14	Luitpold Pharmaceuticals, Inc., Announces NDA Submission for Injectafer (Ferric Carboxymaltose Injection), a Next Generation Intravenous Iron Product
May 14	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
May 16	FDA Advisory Committee Recommends Expanded Use of FluMist
May 18	FDA Advisory Committee Unanimously Votes in Favor of Acambis' Smallpox Vaccine
May 18	New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole
May 21	Roche Receives Approvable Letter for Mircera in the United States
May 21	FDA Issues Approvable Letter for SPD465 (Triple-Bead Mixed Amphetamine Salts) for the Treatment of ADHD in Adults
May 21	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
May 29	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
May 31	Dendreon Announces FDA Confirms Data Required for Provenge Licensure
May 31	TopoTarget elaborates on the specific initiatives to obtain FDA approval of Totect

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New Drug Applications: May 2007

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