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LaViv Approval History

FDA Approved: Yes (First approved June 21, 2011)
Brand name: LaViv
Generic name: azficel-T
Company: Fibrocell Science, Inc.
Treatment for: Wrinkles

Azficel-T is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

Development History and FDA Approval Process for LaViv

DateArticle
Jun 22, 2011Approval Fibrocell Science, Inc. Announces FDA Approval for laViv (azficel-T)
Jan 12, 2011Fibrocell Science, Inc. Announces FDA Accepts for Review Complete Response Submission for Azficel-T
Dec 20, 2010Fibrocell Science, Inc. Submits Complete Response to FDA Regarding Azficel-T
Dec 22, 2009Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles
Oct 12, 2009Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
May 12, 2009Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review
Mar  9, 2009Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration

Further information

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