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Article
Ipsen submits BLA to FDA for Reloxin
Scottsdale, Ariz. - Medicis and Paris-based Ipsen have announced that Ipsen has submitted a Biologics License Application (BLA) to the Food and Drug Administration for the botulinum-toxin product Reloxin to be used in aesthetic indications, news source Prime Newswire reports.
Scottsdale, Ariz. - Medicis, based here, and Paris-based Ipsen have announced that Ipsen has submitted a Biologics License Application (BLA) to the Food and Drug Administration for the botulinum-toxin product Reloxin to be used in aesthetic indications, news source Prime Newswire reports.
Ipsen’s BLA submission reportedly is intended to address concerns cited by the agency when it declined in January to file a Reloxin BLA submitted by Medicis in late 2007.
Medicis plans to market Reloxin in the United States. In March 2006, Ipsen granted Medicis the rights to develop, distribute and commercialize Ipsen’s botulinum-toxin product in the United States, Canada and Japan for aesthetic use by physicians.
Pending FDA acceptance of the Reloxin submission, Medicis will pay Ipsen approximately $25 million in accordance with the companies’ agreement, Prime Newswire reports.
