Biogen Idec (BIIB), Elan (ELN) PDUFA Date on TYSABRI Extended
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Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) said the FDA has extended the initial PDUFA date for its review of the supplemental Biologics License Application (sBLA) for TYSABRI.
The FDA said the extension of the PDUFA date is needed to allow time for review of the changes being incorporated into the Risk Evaluation and Mitigation Strategies (REMS) program for TYSABRI, to be consistent with the anticipated Prescribing Information.
The FDA said the extension of the PDUFA date is needed to allow time for review of the changes being incorporated into the Risk Evaluation and Mitigation Strategies (REMS) program for TYSABRI, to be consistent with the anticipated Prescribing Information.
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