REGULATORY

MHLW Sets Interim Nitrosamine Limit for Atomoxetine, 5 Generic Makers Launch Fresh Recalls

By Takashi Ebisawa, Shinya Sato and Tatsuya Otsuka October 23, 2025
Japan’s Ministry of Health, Labor and Welfare (MHLW) has set a temporary “interim control limit” for nitrosamine impurities in the ADHD treatment atomoxetine to ensure a stable supply of the drug, while five manufacturers have launched voluntary recalls after detecting…

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