FDA Determines Regulatory Review Period for SKYCLARYS and Patent Extension Eligibility
May 10, 2025
May 10, 2025
WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has announced the determination of the regulatory review period for SKYCLARYS, a human drug product developed by Reata Pharmaceuticals, Inc.
The product, which is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older, was approved for marketing on February 28, 2023. SKYCLARYS is designed to address the rare and progres . . .
The product, which is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older, was approved for marketing on February 28, 2023. SKYCLARYS is designed to address the rare and progres . . .