NDA 204399, held by Upsher Smith Labs. Testosterone.
As of Nov 14, 2026, NDA 204399 (Vogelxo), held by Upsher Smith Labs, was first approved by FDA on Jun 4, 2014, with 7 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Vogelxo50MG/5GM PACKET · gel;transdermal | Testosterone | Rx |
| Vogelxo12.5MG/1.25GM ACTUATION · gel, metered;transdermal | Testosterone | Rx |
| Jul 11, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Apr 30, 2020 | Supplement 12Labeling · Standard review | Approved | |
| May 30, 2019 | Supplement 11REMS | Approved | |
| May 10, 2019 | Supplement 10Labeling · Standard review | Approved | |
| Oct 25, 2016 | Supplement 4Labeling · Standard review | Approved | |
| May 12, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 11, 2015 | Supplement 2Labeling · Standard review | Approved | |
| Jun 4, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
