Biogen Idec (BIIB) Said FDA Extends PDUFA Date for BG-12 3 Months
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Biogen Idec (NASDAQ: BIIB) said the FDA has extended the initial PDUFA date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The 3 month extension is a standard extension period.
The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies.
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The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies.
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