Johnson & Johnson and Nippon Shinyaku Gain Japan Approval for Opsumit in Pediatric Pulmonary Arterial Hypertension

Reuters
2025.12.22 06:35
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Johnson & Johnson and Nippon Shinyaku have received approval from Japan's Ministry of Health for Opsumit® tablets for pediatric pulmonary arterial hypertension. The approval includes 10 mg tablets and pediatric dispersible tablets in 1.0 mg and 2.5 mg doses for patients aged three months and older. This decision was based on global and local clinical studies, and the product will be jointly promoted in Japan by both companies.