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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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