Entering text into the input field will update the search result below

FDA to Review Fibrocell Science, Inc.’s (FCSC.OB) Complete Response Submission for Azficel-T

Jan. 12, 2011 2:27 PM ETFCSC1 Comment
Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors.

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced this morning that the U.S. Food & Drug Administration (FDA) has accepted for review its complete response submission for azficel-T, proposed brand name laViv®. The product is designed to treat moderate to severe nasolabial folds and wrinkles. The Prescription Drug User Fee Act (PDUFA) date has been set for June 22, 2011.

“We are pleased that our complete response was accepted and look forward to working closely with the FDA through the review process,” stated David Pernock, Fibrocell Science Chairman and CEO. “If approved, azficel-T will be the first and only personalized cell-based aesthetic treatment.”

The company’s unique approach results in a replenishment of the patient’s own fibroblasts, the cells responsible for releasing collagen, elastin and hyaluronic acid to add strength and elasticity to the skin. Fibrocell Science anticipates conducting studies in additional areas such as further aesthetic applications and for treatment of restrictive burn scars, acne scars, and periodontal disease.

Please see disclaimer on QualityStocks website: disclaimer.qualitystocks.net

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

Recommended For You

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.