New Drug Applications: July 2008

July 1	EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist
July 1	Alpharma Announces the Resubmission of a New Drug Application for Embeda Capsules
July 1	ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine
July 1	VioQuest Pharmaceuticals Submits 510(k) Application to FDA for Xyfid, a Novel Topical Agent for the Treatment of Various Skin Disorders
July 7	Digestive Care, Inc. Announces the Filing of the First Module of NDA Submission for Pancrecarb (pancrelipase)
July 14	FDA Accepts Genta's NDA Amendment as Complete Response for Genasense Treatment of Chronic Lymphocytic Leukemia
July 14	FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
July 15	Amgen's FDA Nplate Approval Statement Retracted
July 16	Sciele Pharma Announces That the FDA Has Issued an Approvable Letter for the Head Lice Treatment
July 22	Xanodyne Receives Approvable Letter From the FDA for Zipsor Capsules
July 23	NexMed Receives FDA Response for Topical ED Product
July 23	Bristol-Myers Squibb and AstraZeneca Submit New Drug Application in the United States and Marketing Authorization Application in Europe for Onglyza (saxagliptin) for the Treatment of Type 2 Diabetes
July 28	Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures
July 28	CVT Announces That FDA Continues to Review Ranexa Applications
July 28	Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
July 29	Meda: The FDA has accepted for filing the registration application for Sublinox
July 29	UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain
July 29	FDA Advisory Committee Recommends Approval of Actemra (tocilizumab) for the Treatment of Rheumatoid Arthritis
July 30	Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.

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New Drug Applications: July 2008

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