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  • GSK receives administrative disposition in KOR
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | Jul 30, 2024 05:51am
for failure misreporting drug substance specification and container mislabeling
MFDS announces 2 administrative dispositions¡¦Will pay a fine for Seretide as a substitution to the disposition
The global pharmaceutical company GlaxoSmithKline (GSK) has received administrative dispositions for failing to report changes to the specifications of the main ingredient of its active pharmaceutical ingredient and for issues relating to the drug containers.

The Ministry of Food and Drug Safety recently imposed a fine of KRW 52.2 million in substitution of the 15-day suspension on the sale of ¡®Duac Gel 5%,¡¯ a 6-month import suspension on ¡®Flixoteide Junior Evohaler 50 micrograms,¡¯ and a 6-month import suspension on ¡®Seretide 100-250-500 Diskus.¡¯

Duac Gel is a gel-type mild-to-moderate treatment for acne that contains clindamycin phosphate and benzoyl peroxide. It is prescribed as an alternative that can
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