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
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