Ipsen and Medicis announce submission of ReloxinÂ® BLA in aesthetics to the FDA
Medicis (NYSE:MRX) and Ipsen (Euronext: IPN) today announced that Ipsen has submitted a Biologics License Application (â€œBLAâ€) for the botulinum toxin type A, ReloxinÂ® , in aesthetic indications (glabellar lines) to the U.S. Food and Drug Administrationâ€™s (â€œFDAâ€) Division of Dermatology and Dental Products, within the Center for Drug Evaluation and Research.
This BLA submission by Ipsen is intended to address the concerns cited by the FDA when it declined to file the ReloxinÂ® 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 ReloxinÂ® submission. Subject to approval of the BLA by the FDA, Medicis intends to commercialize ReloxinÂ® in the U.S. 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.