FDA
22nd July 2014

Meeting Announcement – Oral Testosterone Undecanoate Tablets

During this meeting, the committees will discuss new drug application (NDA) 206089, (oral testosterone undecanoate tablets), submitted by Clarus Therapeutics, for the proposed indication of testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Meeting Announcement – Oral Testosterone Undecanoate Tablets

September 18, 2014 8:00 a.m. to 1:00 p.m.: Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement

Where:

College Park Marriott Hotel and
Conference Center
3501 University Blvd. East
Hyattsville, Maryland

During this meeting, the committees will discuss new drug application (NDA) 206089, (oral testosterone undecanoate tablets), submitted by Clarus Therapeutics, for the proposed indication of testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Please click HERE for the current roster of the Bone, Reproductive and Urologic Drugs Advisory Committee.

Please click HERE for the current roster of the Drug Safety and Risk Management Advisory Committee.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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