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# Review Period Set for Opsumit
- URL: https://www.fdaweb.com/review-period-set-for-opsumit/
- Published: 2016-03-10T12:00:00.000Z
- Updated: 2026-09-15T02:42:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135036

*Federal Register* Notice: FDA has determined the regulatory review period for Actelion Pharmaceuticals’ Opsumit (macitentan) is 1,935 days for extending a patent which claims the human drug product. Opsumit is indicated for treating pulmonary arterial hypertension to delay disease progression. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05389.pdf?ref=fdaweb.com)