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FDA postpones first-cycle review of Dysport
French pharmaceutical company Ipsen says the U.S. Food and Drug Administration (FDA) will not complete its first-cycle review of Ipsen?s botulinum toxin type A product Dysport until the end of the year, Reuters reports.
Paris — French pharmaceutical company Ipsen says the U.S. Food and Drug Administration (FDA) will not complete its first-cycle review of Ipsen’s botulinum toxin type A product Dysport until the end of the year, Reuters reports.
The company noted that the FDA had not requested additional safety or clinical studies and that the regulatory decision would not affect the timing of the product launch.
Dysport is used outside the United States for treatment of cervical dystonia and seven other indications. The FDA originally said it would release its decision Sept. 29, but has postponed that until Dec. 28.
Another report by news source Businesswire cites the reason for the postponement as the FDA’s request (and time needed for subsequent review) of a Risk Communication Plan to ensure safe use of the product.
Dysport is authorized for use in more than 70 countries.
