LaViv
Generic name: azficel-T
Treatment for: Wrinkles
FDA Accepts Isolagen's BLA
Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review
EXTON, Pa., May 08, 2009 /PRNewswire-FirstCall/ -- Isolagen, Inc. today announced that the United States Food and Drug Administration ("FDA") has completed its initial review of the Company's Biologics License Application ("BLA") related to its Nasolabial Fold/Wrinkles product candidate and that the FDA has accepted (or filed) the BLA for full review.
In a communication received from the FDA on May 7, 2009, the FDA noted that it had completed its initial review of the Company's BLA to determine its acceptability for filing and that the FDA has filed the Company's application. The FDA noted that its review completion target date is January 4, 2010.
The FDA's filing review is only a preliminary review, and deficiencies may be identified during full review of the BLA. Also, the acknowledgment of filing by the FDA does not mean that the FDA has issued a license, nor did the FDA represent any evaluation of the adequacy of the data submitted.
Isolagen, Inc. is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies. The company's technology platform includes the Isolagen Process, a cell processing system for skin and tissue rejuvenation which is currently in clinical development for a broad range of aesthetic and therapeutic potential applications including wrinkles, acne scars, burns and periodontal disease. Isolagen also commercializes a scientifically-advanced line of skincare systems through its majority-owned subsidiary, Agera(R) Laboratories, Inc. For additional information, please visit .
CONTACT: Mike Beyer, +1-773-463-4211, beyer@sambrown.com
Ticker Symbol: (NYSE:ILE),(NYSE:ILE)
Terms and conditions of use apply Copyright © 2009 PR Newswire Association LLC. All rights reserved. A United Business Media Company
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Posted: May 2009
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LaViv (azficel-T) FDA Approval History
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