Tlando FDA 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 Timeline for Tlando
|Nov 11, 2019||Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA|
|May 14, 2019||Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019|
|May 9, 2018||Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration|
|Jan 10, 2018||Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism|
|Aug 14, 2017||Lipocine Announces FDA Acknowledgement of Tlando (LPCN 1021) NDA Resubmission|
|Aug 9, 2017||Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism|
|Jun 29, 2016||Lipocine Receives Complete Response Letter (CRL) for LPCN 1021 From U.S. FDA|
|Nov 12, 2015||Lipocine Announces PDUFA Goal Date for LPCN 1021 NDA|
|Oct 29, 2015||FDA Accepts for Filing Lipocine's NDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021|
|Aug 31, 2015||Lipocine Submits NDA to FDA for Its Oral Testosterone Replacement Product Candidate, LPCN 1021|
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