FDA approve testosterone undecanoate with restructions

FDA approve testosterone undecanoate with restructions

Postby MikeC » Sun Apr 03, 2016 7:22 am

Interesting articles, covering the US approval of "testosterone undecanoate" injections.

http://www.fda.gov/downloads/Drugs/Drug ... 389149.pdf
http://www.medscape.com/viewarticle/821632

Interesting that they rejected it 3 times before approving, and added restrictions on dispensing

Lower dose that the European version with more frequent injections...
MikeC
 
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