What is Vogelxo used for?

Indications and Usage, quoted from the label by Upsher-Smith Laboratories, LLC (NDA204399). Cross-references to other label sections are left out.

Vogelxo is indicated for 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 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 levels 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 levels but have gonadotropins in the normal or low range.

Limitations of Use:

• Safety and efficacy of Vogelxo in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.
• Safety and efficacy of Vogelxo in males less than 18 years old have not been established [see Use in Specific Populations].
• Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administrationand Clinical Pharmacology].

Source: DailyMed label, set id 2dd150f6-cdfd-4d51-8888-12b288f26262, version 13, effective July 14, 2025. NDC 0245-0871, one of 1 listing for this product.