RALEIGH, N.C., March 11, 2021 – Marius Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 31, 2021 for the review of the KYZATREX® New Drug Application (NDA) for primary and secondary male hypogonadism. KYZATREX®, an oral testosterone undecanoate softgel, had one of the most comprehensive Phase 3 trials in the testosterone space and if approved, has the potential to be the only first-action approval oral testosterone product on the market. The company plans to launch immediately following product approval.
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