What is Tlando used for?

Indications and Usage, quoted from the label by Verity Pharmaceuticals Inc. (NDA208088). Cross-references to other label sections are left out.

TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range.
• Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations of Use

• Safety and efficacy of TLANDO in males less than 18 years old have not been established.
• Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Source: DailyMed label, set id 4b0b92e9-6d3c-a0e5-e1c7-342999f72580, version 5, effective February 25, 2026. NDC 74676-0112, one of 1 listing for this product.