New Drug Applications: December 2007

December 3	FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension
December 3	Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA
December 4	Centocor and Janssen-Cilag Submit Applications Requesting Approval of Ustekinumab in the U.S. and Europe for Treatment of Moderate to Severe Plaque Psoriasis
December 6	Ipsen Submits a Biologics License Application in Cervical Dystonia to the FDA for Dysport
December 6	Ipsen and Medicis Announce Submission of Reloxin in Aesthetics to the FDA
December 7	Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
December 7	FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated With Huntington Disease
December 7	Neurochem Announces Eprodisate (Kiacta) Receives Acknowledgement of Complete Response and is Granted Class 2 Review
December 7	DOR BioPharma Announces Results of orBec End of Review Conference with the FDA
December 12	FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation
December 12	ProEthic Pharmaceuticals Announces Acceptance of PRO-513 New Drug Application for Migraine
December 13	Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA
December 13	Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
December 17	MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA
December 17	Wyeth Provides Update on Regulatory Review of Viviant (bazedoxifene)
December 17	GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Cervical Cancer Vaccine
December 19	Pro-Pharmaceuticals Selects SAFC, a Division of Sigma-Aldrich, to Submit a Drug Master File
December 19	AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients
December 20	Introgen Plans to Expand Biomarker Database in Phase 3 Trials and File BLA and MAA for Advexin in Advanced Head and Neck Cancer in First Half of 2008
December 20	GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder
December 20	Eurand Completes New Drug Application for Zentase
December 21	Ligand Earns $1 Million Milestone Payment as GlaxoSmithKline Submits New Drug Application for Promacta (eltrombopag)
December 21	Jerini Receives NDA Filing Acceptance and Priority Review from the FDA for Icatibant in the Treatment of HAE
December 21	New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Administration
December 21	Pfizer Receives Approvable Letter from FDA for Dalbavancin
December 26	Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
December 26	Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
December 27	Noven Announces FDA Tentative Approval of Stavzor Valproic Acid Delayed Release Capsules

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New Drug Applications: December 2007

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