New Drug Applications Archive - March 2010
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March 1, 2010
- FDA Accepts VIAject NDA for Review
- Vion Pharmaceuticals Receives Response From FDA on Special Protocol Assessment for Onrigin
March 2, 2010
- FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients
- U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro
- Adventrx Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
- VIVUS Announces FDA Acceptance of Qnexa New Drug Application for Treatment of Obesity
- FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone
March 5, 2010
March 8, 2010
March 9, 2010
- Actelion Pharmaceuticals Ltd (CH) - Actelion receives FDA complete response letter for Zavesca (miglustat) for the treatment of Niemann-Pick type C disease
- ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay
March 10, 2010
- FDA Advisory Committee Recommends Approval of InterMune's Esbriet (pirfenidone) for Idiopathic Pulmonary Fibrosis
- Dainippon Sumitomo Pharma America Announces FDA Acceptance of Lurasidone New Drug Application for Treatment of Schizophrenia
March 15, 2010
March 19, 2010
- A.P. Pharma Receives FDA Complete Response Letter for APF530
- Adventrx Receives Brand Name Acceptance for ANX-530
- Savient Resubmits Biologics License Application for Krystexxa (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy
March 22, 2010
- U.S. Food And Drug Administration Accepts New Drug Application For Once-Daily Fixed Dose Combination Of Onglyza (Saxagliptin) And Extended Release Metformin For The Treatment Of Type 2 Diabetes Mellitus In Adults
- FDA Confirms Date for Advisory Committee Review of the Tesamorelin New Drug Application
- CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
March 23, 2010
March 24, 2010
March 25, 2010
March 26, 2010
March 30, 2010
- AstraZeneca and Abbott Receive FDA Complete Response Letter on Certriad New Drug Application
- New drug application for voclosporin accepted for priority review by FDA
- Ikaria Acquires New Drug Application for Lucassin
- Savient Announces Krystexxa Resubmitted BLA Accepted for Review by the FDA
- Lux Biosciences' Luveniq Receives FDA Priority Review
March 31, 2010
- Depomed Announces Submission of New Drug Application for Investigational Postherpetic Neuralgia Treatment DM-1796
- Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU
- Orexigen Therapeutics Submits Contrave New Drug Application to FDA for the Treatment of Obesity
