New Drug Applications Archive - December 2007
Get news by email or subscribe to our news feeds.
December 3, 2007
- FDA Issues Approvable Letter for Bystolic (nebivolol) for the Treatment of Hypertension
- Treanda New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA
December 4, 2007
December 6, 2007
- Ipsen Submits a Biologics License Application in Cervical Dystonia to the FDA for Dysport
- Ipsen and Medicis Announce Submission of Reloxin in Aesthetics to the FDA
December 7, 2007
- FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa
- Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
- FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated With Huntington Disease
- Neurochem Announces Eprodisate (Kiacta) Receives Acknowledgement of Complete Response and is Granted Class 2 Review
- DOR BioPharma Announces Results of orBec End of Review Conference with the FDA
December 12, 2007
- FDA Advisory Committee Recommends Approval of Kynapid for Acute Atrial Fibrillation
- ProEthic Pharmaceuticals Announces Acceptance of PRO-513 New Drug Application for Migraine
December 13, 2007
- Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA
- Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
December 17, 2007
- MGI Pharma Announces Aquavan NDA Accepted for Review by U.S. FDA
- Wyeth Provides Update on Regulatory Review of Viviant (bazedoxifene)
- GlaxoSmithKline Receives FDA 'Complete Response' Letterfor Cervarix Cervical Cancer Vaccine
December 19, 2007
- Pro-Pharmaceuticals Selects SAFC, a Division of Sigma-Aldrich, to Submit a Drug Master File
- AMAG Pharmaceuticals, Inc. Submits New Drug Application to FDA for Ferumoxytol in Chronic Kidney Disease Patients
December 20, 2007
- 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
- GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder
- Eurand Completes New Drug Application for Zentase
December 21, 2007
- Jerini Receives NDA Filing Acceptance and Priority Review from theFDA for Icatibant in the Treatment of HAE
- New Drug Application for Tolvaptan, Otsuka's Investigational NovelOral Treatment for Worsening Heart Failure and Hyponatremia,Accepted by the U.S. Food and Drug Administration
- Ligand Earns $1 Million Milestone Payment as GlaxoSmithKline Submits New Drug Application for Promacta (eltrombopag)
- Pfizer Receives Approvable Letter from FDA for Dalbavancin
December 26, 2007
- Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis - Dec 26, 2007
- Pharmacyclics Receives Non-Approvable Letter from the FDA for Xcytrin for the Treatment of Lung Cancer Brain Metastases
