New Drug Applications Archive

New Drug Applications: June 2008

June 2	ProStrakan Presents Update on Sancuso US Regulatory Review Status
June 4	Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5%
June 4	Indevus Pharmaceuticals Provides Update on Nebido NDA Status
June 6	Genta Submits NDA Amendment to FDA for Genasense as Treatment of Chronic Lymphocytic Leukemia
June 10	Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy
June 17	Genzyme Files Applications for Approval of Mozobil in the United States and Europe
June 18	FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
June 19	Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase)
June 19	Discovery Labs and FDA Meet to Clarify Limited Items in Surfaxin Approvable Letter
June 20	Merck Provides Update on U.S. Regulatory Status of MK-0524A (ER niacin/laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin)
June 23	Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for Promacta NDA
June 23	Jerini to Submit Complete Response to the FDA for Icatibant in the Treatment of HAE
June 24	FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative Antiplatelet Drug, Prasugrel
June 26	U.S. Food and Drug Administration Advisory Committee Recommends Approval of Tolvaptan, an Investigational Treatment for Hyponatremia
June 27	Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis
June 27	Schering-Plough and Merck Announce Withdrawal of Loratadine/Montelukast NDA and Termination of Respiratory Joint Venture
June 30	New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
June 30	Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product
June 30	Introgen Submits Advexin Regulatory Applications in the U.S. and Europe
June 30	GlaxoSmithKline Responds to FDA on Cervarix and Plans to Submit Final Study Data for Approval
June 30	Indevus Receives Approvable Letter from FDA for Nebido
June 30	Acusphere Announces FDA Acceptance of Imagify NDA for Detection of Coronary Artery Disease

New Drug Applications Archive

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