Medicis Pharmaceutical earned an "incomplete" grade on its latest BLA. The FDA has refused to accept the application for Reloxin--botulinum toxin type A--for a variety of shortfalls, including a gap in how it would live up to its responsibilities as a manufacturer. Another red flag: the application "included letters of authorization supporting a separate BLA submitted by Ipsen." For its part, Medicis, which makes wrinkle-fillers and other products, says it believes its application is strong, adding they will continue to work with the agency. Medicis also noted that the denial was likely to delay any product launch. Investors responded to the fiasco by bidding down company shares by 11 percent.
- check out the AP report
Medicis wins anti-wrinkle drug Reloxin in licensing pact. Report