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Aveed Approval History

  • FDA approved: Yes (First approved March 5th, 2014)
  • Brand name: Aveed
  • Generic name: testosterone undecanoate
  • Dosage form: Intramuscular Injection
  • Previous name: Nebido
  • Company: Endo Pharmaceuticals Inc.
  • Treatment for: Hypogonadism, Male

Aveed (testosterone undecanoate) is a long-acting androgen depot injection for the treatment of male hypogonadism.

Development History and FDA Approval Process for Aveed

Mar  6, 2014Approval FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy
Sep  5, 2013FDA Accepts Endo's Complete Response Submission to New Drug Application for Aveed (Testosterone Undecanoate) Injection
May 31, 2013Endo Pharmaceuticals Provides Regulatory Update On Aveed (Testosterone Undecanoate) Injection
Dec  3, 2009Endo Pharmaceuticals Provides Regulatory Update on Aveed (Testosterone Undecanoate) Injection
Sep  3, 2009Endo Pharmaceuticals Gives Update on Regulatory Status of Testosterone Undecanoate for Men with Hypogonadism
Mar 12, 2009FDA Accepts Complete Response Submission to New Drug Application for Nebido
Sep 26, 2008Indevus and FDA Agree on Path Forward for Nebido
Jun 30, 2008Indevus Receives Approvable Letter from FDA for Nebido
Jun  4, 2008Indevus Pharmaceuticals Provides Update on Nebido NDA Status
Nov  1, 2007FDA Accepts New Drug Application for Nebido Submitted by Indevus
Aug 28, 2007Indevus Announces Submission of New Drug Application for Nebido

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