South Korea’s Ministry of Food and Drug Safety issued a pair of administrative penalties to GSK for manufacturing and labeling problems on certain asthma and acne treatments, Korea Biomedical Review reports.
In its rebuke of GSK, the regulatory agency said the company violated regulations by failing to report changes it made to the APIs used to make Seretide 100 Discus (fluticasone-salmeterol), Seretide 250 Discus, Seretide 500 Discus, and Flixotide Junior Evohaler 50, according to KBR. The drugs are used to treat asthma.
The company was also scolded for confusing manufacturing numbers and expiration dates on its labels for acne drug Duacgel 5% (clindamycin phosphate-containing benzoyl peroxide), according to the publication.
As part of its action, the agency imposed a 15-day sales suspension from Aug. 1 to 15 on Duacgel 5%, according to KBR.
GSK was fined 52.2 million won ($37,680) on Seretide 100 Discus, Seretide 250 Discus, and Seretide 500 Discus. GSK was also hit with a six-month import suspension on Flixotide Junior Evohaler 50mcg that runs from Aug. 1, 2024, to Jan. 31, 2025.
Fierce reached out to GSK for comment on the regulatory action.