ARTICLE | Clinical News
Clarus resubmits NDA for oral testosterone replacement therapy Jatenzo
July 28, 2017 6:12 AM UTC
Last month, Clarus Therapeutics Inc. (Northbrook, Ill.) said it resubmitted an NDA to FDA for Jatenzo testosterone undecanoate to treat low testosterone in males with hypogonadism.
In 2014, FDA’s advisory committees voted against approval of the product (see BioCentury, Sept. 22, 2014). FDA subsequently issued a complete response letter to the initial NDA...
BCIQ Company Profiles