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Vitaros Approval Status

  • FDA Approval Status: Under Review
  • Brand name: Vitaros
  • Generic name: alprostadil
  • Dosage form: Cream
  • Previous name: Alprox-TD
  • Company: Apricus Biosciences, Inc.
  • Treatment for: Erectile Dysfunction

Vitaros (alprostadil) is a topical vasodilator cream in development for the treatment of erectile dysfunction.

Development Status and FDA Approval Process for Vitaros

Feb 16, 2018Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros
Aug 29, 2017Apricus Biosciences Files NDA Resubmission for Vitaros
Nov 18, 2016Apricus Biosciences Provides Update on Vitaros NDA Following Receipt of FDA Feedback
Oct 20, 2008NexMed Discusses End of Review Meeting for Vitaros
Jul 23, 2008NexMed Receives FDA Response for Topical ED Product
Nov 20, 2007NexMed Confirms FDA Acceptance of NDA for Erectle Dysfunction Product
Sep 24, 2007NexMed Files NDA for Proprietary Erectile Dysfunction Treatment

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