LPCN 1021 Approval Status
- FDA approved: No
- Brand name: LPCN 1021
- Generic name: testosterone
- Company: Lipocine Inc.
- Treatment for: Hypogonadism, Male
LPCN 1021 (testosterone) is an oral testosterone replacement therapy in development for the treatment of males with conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.In June 2016, Lipocine Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application for LPCN 1021 cannot be approved in its present form.
Development Status and FDA Approval Process for LPCN 1021
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