Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. NDA 213006, held by Sumitomo Pharma Am. Vibegron.
As of Nov 13, 2026, NDA 213006 (Gemtesa), held by Sumitomo Pharma Am, was first approved by FDA on Dec 23, 2020, with 2 approved supplements and 0 published complete response letters.
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of: overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH). 1.1 Overactive Bladder in Adults GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. 1.
| Dec 18, 2024 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 23, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Gemtesa75MG · tablet;oral | Vibegron | RxReference drug |
| Dec 18, 2024 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Oct 8, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Dec 23, 2020 | Original applicationNew molecular entity · 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
