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Tlando Approval Status

FDA Approved: No
Brand name: Tlando
Generic name: testosterone
Previous Name: LPCN 1021
Company: Lipocine Inc.
Treatment for: Hypogonadism, Male

Tlando (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.

Development Status and FDA Approval Process for Tlando

DateArticle
May 14, 2019Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019
May  9, 2018Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration
Jan 10, 2018Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism
Aug 14, 2017Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission
Aug  9, 2017Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism
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

Further information

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