Aveed Approval History

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

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

FDA Approval History for Aveed

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)