The Korean Ministry of Food and Drug Safety (MFDS), headed by Director Oh Yu-kyung, announced a revision of the approval conditions for oral aripiprazole products.
The key change is the addition of Stevens‑Johnson syndrome to the list of adverse reactions, based on post‑marketing reports in Korea.
On the 7th, the MFDS Drug Safety Evaluation Division prepared a draft amendment after reviewing recent adverse case reports and domestic and international approval status, and began a public comment process with the affected companies.
The amendment targets 56 product items from 12 companies, including products such as Avilify tablets from Korea Otsuka Pharmaceutical and items from Hyundai Pharm.
Regulatory UpdatesSep 18, 2026•3 min read
MFDS to Add Stevens-Johnson Syndrome to Labels of 56 Oral Aripiprazole Products
South Korea’s MFDS will amend the approval conditions for 56 oral aripiprazole medicines, adding Stevens-Johnson syndrome as a reported adverse reaction. The change involves 12 manufacturers.
Compiled by the Pharmacountry team · Source: KPA News
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