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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

Jun 29, 2016Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA
Nov 12, 2015Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA
Oct 29, 2015FDA Accepts for Filing Lipocine's NDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021
Aug 31, 2015Lipocine Submits NDA to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021

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