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news.Medicis and Ipsen have announced that Ipsen has submitted a biologics license application for the botulinum toxin type A, Reloxin, in aesthetic indications to the FDA.
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This biologics license application (BLA) submission by Ipsen is intended to address the concerns cited by the FDA when it declined to file the Reloxin BLA in January 2008, which Medicis had submitted in late 2007. Standard response timeframe from the FDA is expected approximately 10 months following receipt of the Reloxin submission. Subject to approval of the BLA by the FDA, Medicis intends to commercialize Reloxin in the US in accordance with the long-standing arrangement between Medicis and Ipsen.
Changes from the original BLA submission relate primarily to sponsorship and ownership of the filing. The substantive elements of the original submission remain unchanged.
Jonah Shacknai, chairman and CEO of Medicis, said: “We are pleased to announce this submission of the BLA for Reloxin in aesthetics with FDA. We continue to believe the Reloxin BLA is strong, and anticipate entering in the growing, multi-million dollar aesthetic botulinum toxin market in the US upon FDA approval.”