4 May 2020 - Fensolvi is the only six-month, subcutaneously administered leuprolide acetate approved for the treatment of paediatric patients two years of age and older with central precocious puberty.
Tolmar Pharmaceuticals, Inc. announced today that the U.S. FDA has approved its new drug application for Fensolvi (leuprolide acetate) for injectable suspension for the treatment of paediatric patients two years of age and older with central precocious puberty (CPP).
CPP is a rare disease defined as the onset of puberty before age eight in girls and before age nine in boys.