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Fensolvi Approval History

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 History and FDA Approval Process for Fensolvi

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

Further information

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