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...