Biologics

Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration

Published in Drug Law Weekly, March 24th, 2009

Isolagen, Inc. (AMEX:ILE) announced that the Company has submitted a Biologics License Application (BLA) for Isolagen Therapy(TM), a novel, first-in-class cellular therapy for the treatment of wrinkles/nasolabial folds, to the U.S. Food and Drug Administration (FDA). The Company's wrinkles/nasolabial folds Phase III trials were conducted under an FDA Special Protocol Assessment.

"This BLA submission is a significant regulatory milestone for Isolagen," said Declan Daly, Chief Executive Officer and President of Isolagen. "We believe that the Isolagen Therapy(TM), if approved, would represent a new class of treatment in the facial aesthetic arena whereby patients will...

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Source: Drug Law Weekly (2009-03-24)

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