FDA rejects Lipocine's new testosterone drug

The Food and Drug Administration denied Lipocine's New Drug Application for its oral testosterone drug.

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.

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