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