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Fortesta Approval History

  • FDA approved: Yes (First approved December 29th, 2010)
  • Brand name: Fortesta
  • Generic name: testosterone
  • Dosage form: Gel
  • Company: Endo Pharmaceuticals
  • Treatment for: Hypogonadism, Male

Fortesta (testosterone) Gel is a topical androgen indicated for replacement therapy in male hypogonadism.

Development History and FDA Approval Process for Fortesta

Dec 30, 2010Approval Endo Pharmaceuticals Receives FDA Approval for Fortesta (Testosterone) Gel as a Class III Product for Topical Use for Men With Low Testosterone
Jul  1, 2010Endo Pharmaceuticals Completes Next Step in Regulatory Process for Fortesta for Men With Low Testosterone
Oct 22, 2009Endo Pharmaceuticals Gives Update on Regulatory Status of Fortesta
Aug 26, 2009Endo Pharmaceuticals to Partner With ProStrakan to Commercialize Fortesta in the U.S.

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