Posted by Michael Wonder on 28 Sep 2021
Lipocine announces FDA affirmation of Class 1 NDA resubmission for Tlando
28 September 2021 - Lipocine today announced the U.S. FDA has affirmed the resubmission of its new drug application for Tlando, its oral testosterone product, will be a Class 1 resubmission.
The FDA granted tentative approval to Tlando in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) in December 2020.
