Skip to main content

Fensolvi FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2020.

FDA Approved: Yes (First approved May 1, 2020)
Brand name: Fensolvi
Generic name: leuprolide acetate
Dosage form: Injection
Company: Tolmar Pharmaceuticals, Inc.
Treatment for: Precocious Puberty

Fensolvi (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

Development timeline for Fensolvi

DateArticle
May  5, 2020Approval FDA Approves Fensolvi (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.