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Two botulinum toxin BLAs become one approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's April 30 approval of Ipsen's botulinum neurotoxin type A complex reunited therapeutic and cosmetic indications that the company had pursued separately. Ipsen kept the therapeutic use (treatment of cervical dystonia) for itself and licensed cosmetic use for wrinkles, or glabellar lines, to Medicis. The cervical dystonia use was submitted as Dysport and the glabellar lines BLA was submitted as Reloxin in late 2007. The BLAs followed different paths before FDA converted Reloxin into an efficacy supplement under the Dysport (abobotulinumtoxinA) BLA - and united the products under the Dysport name - for approval. The review appears to have been marked by risk management issues: a user fee extension so FDA could review a risk communication plan was followed by a Dec. 29, 2008, "complete response" letter requesting a REMS. The BLA itself was also an issue: FDA refused to file Reloxin in late 2007 due to administrative issues; it was resubmitted March 12, 2008. FDA later extended the user fee goal from January 2009 to April 13, 2009

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