Hypogonadism Archives - MPR

Hypogonadism

MPR Weekly Dose Podcast Episode 21

This week on the Pod we cover an insulin pump recall; Pharmacies running out of supplies in light of Covid-19 fears; Investigational Alzheimer disease treatments not meeting trial end points; A new cardiac ultrasound device; and a new oral testosterone replacement therapy.

FDA Again Rejects NDA for Oral Testosterone Product Candidate

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Lipocine regarding the New Drug Application for Tlando (testosterone undecanoate), an oral testosterone product candidate for testosterone replacement therapy in adult males with primary hypogonadism or hypogonadotropic hypogonadism. In the CRL, the Agency noted that the trial establishing the efficacy of…