FDA, Repros meeting: no new safety trials due for Androxal
By Randy Osborne
Friday, February 7, 2014
The “not-testosterone” mantra long chanted by Repros Therapeutics Inc. with regard to its Androxal (enclomiphene), for secondary hypogonadism finally took hold, and the FDA agreed that the company will not need new safety tests before submitting the new drug application (NDA) before the end of this year.
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