Gemtesa vibegron fda approval?

Yes. Gemtesa (vibegron) was FDA-approved in December 2020 for adults with overactive bladder (OAB).

- What it is: A once-daily oral beta-3 adrenergic agonist that helps relax the bladder to reduce OAB symptoms (urgency, frequency, and urge incontinence).
- Dose (adult): 75 mg by mouth once daily, with or without food.
- About the approval: Based on Phase 3 trials showing benefit versus placebo in reducing urge incontinence episodes and other OAB symptoms.
- Common side effects: Urinary tract infection, hypertension, headache, nasopharyngitis.
- Important notes: Not approved for children. As with any medication, discuss with a clinician about suitability, dosing, potential interactions, and contraindications.

If you’d like, I can pull up the exact FDA labeling or provide a link to the FDA press release.