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Tlando FDA Approval History

Last updated by Judith Stewart, BPharm on April 5, 2022.

FDA Approved: Yes (First approved March 28, 2022)
Brand name: Tlando
Generic name: testosterone
Dosage form: Capsules
Company: Antares Pharma, Inc.
Treatment for: Hypogonadism, Male

Tlando (testosterone) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

  • Testosterone deficiency (male hypogonadism) is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. 
  • Tlando capsules are administered orally twice daily with food.
  • The Tlando product label carries a boxed warning for increases in blood pressure that can increase the risk of major adverse cardiovascular events.
  • Tlando is associated with the following warnings and precautions: polycythemia, worsening of benign prostatic hyperplasia (BPH) and potential risk of prostate cancer, venous thromboembolism, potential for adverse effects on spermatogenesis, edema, sleep apnea, changes to serum lipid profile, and changes to serum prolactin levels.
  • Common adverse reactions include increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain.

Development timeline for Tlando

Mar 29, 2022Approval FDA Approves Tlando (testosterone undecanoate) for Male Hypogonadism
Jan 27, 2022Lipocine Announces Peer-Reviewed Publication of Phase 3 Study Results for TLANDO
Sep 28, 2021Lipocine Announces FDA Affirmation Of Class 1 NDA Resubmission For TLANDO®
Dec  8, 2020Lipocine Announces Tentative Approval of TLANDO
Nov 11, 2019Lipocine Receives Complete Response Letter for TLANDO™ from U.S. FDA
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.