New Drug Applications Archive

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July 2008

July 1

EPIX Pharmaceuticals Announces Resubmission of New Drug Application for Vasovist Alpharma Announces the Resubmission of a New Drug Application for Embeda Capsules ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine VioQuest Pharmaceuticals Submits 510(k) Application to FDA for Xyfid, a Novel Topical Agent for the Treatment of Various Skin Disorders

July 3

Labopharm Submits Complete Response to FDA as a Result of Outcome of Appeal Process for Once-Daily Tramadol

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 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 17

FDA Accepts Labopharm's Response for Once-Daily Tramadol as Complete Class 2 Response

July 22

Xanodyne Receives Approvable Letter From the FDA for Zipsor Capsules

July 23

NexMed Receives FDA Response for Topical ED Product 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 24

Supplemental New Drug Application for Risperdal Consta Submitted to the FDA for the Treatment of Bipolar Disorder

July 28

Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures CVT Announces That FDA Continues to Review Ranexa Applications 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 UCB Receives Not-Approvable Letter from FDA for Lacosamide for Diabetic Neuropathic Pain 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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