The National Medical Products Administration (NMPA) has released a notification announcing that GlaxoSmithKline’s (GSK) Avodart (dutasteride) has been given the green light to resume import, sales, and use in China, effective from September 1, 2023. This follows a previous suspension due to an unsuccessful overseas site inspection by the NMPA in October 2022, which found that the drug was not processed in line with China registration standards and had deficiencies in microbial contamination risk control. As a result, the NMPA suspended the import, sale, and use of the drug, which was listed in the fifth round of the national volume-based procurement (VBP) program, rendering it ineligible for VBP filing from October 31, 2022, to April 29, 2024.
Dutasteride, initially approved for marketing in the United States in November 2001 and entering the Chinese market in April 2011, is used for the treatment of urinary retention and prostatic hyperplasia. The drug works by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), thereby reducing the prostate volume and improving lower urinary tract symptoms.- Flcube.com
