LPCN 1021 is a new twice-a-day oral testosterone replacement therapy intended to treat men with a deficiency or absence of endogenous testosterone.
The FDA cited deficiencies in the dosing algorithm for the drug’s label as the reason for denial.
Salt Lake City-based Lipocine plans to meet with the FDA to further address the drug’s issues and work toward approval.
More articles on the drug market:
FDA approves drug for treatment of 6 types of hepatitis C
Roche’s new MS drug to hit market sooner than expected
Novartis partners with Xencor to develop bispecific antibodies
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