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
|Mar 6, 2014|| 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|
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