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Osiris Therapeutics, Inc.
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SOPP 8406: CBER Processing of PDUFA Payment Information
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Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot 4030026 Through October 31, 2014
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September 23, 2013 Approval Letter
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Dosing Decrease to 1.0 mL/kg (50 mg/kg) and Expiration Date Extension for Botulism Immune Globulin Intravenous (Human) (BIG-IV) Lot 5 to March 02, 2015.
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September 5, 2013 Approval Letter
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FluLaval Quadrivalent
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August 16, 2013 Approval Letter
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Summary Basis for Regulatory Action (BLA/STN# 125300/226)
Date:Â August 1, 2013 From:Â Cara R. Fiore, Ph. D. BLA/ STN#:Â 125300_226 Applicant Name:Â Novartis Vaccines and Diagnostics, Inc. Date of Submission (CBER received): April 13, 2011 PDUFA Goal Date: August 1, 2013 Proprietary Name/ Established Name:Â Menveo [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] Indication: Active immunization to prevent invasive meningococcal disease caused…