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Isologen gets FDA nod for nasobial fold/wringles product candidate
Exton, Pennsylvania | Thursday, May 14, 2009, 08:00 Hrs  [IST]

Isolagen Inc 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 is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies.

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