NDA 205488, held by Acerus. Testosterone.
As of Nov 15, 2026, NDA 205488 (Natesto), held by Acerus, was first approved by FDA on May 28, 2014, with 3 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Natesto 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 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Natesto5.5MG/0.122GM ACTUATION · gel, metered;nasal | Testosterone | RxReference drug |
| Jul 11, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Oct 25, 2016 | Supplement 2Labeling · Standard review | Approved | |
| May 11, 2015 | Supplement 1Labeling · Standard review | Approved | |
| May 28, 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
