Zydus gets tentative OK for generic Opsumit

Patients with pulmonary arterial hypertension will soon have a new generic treatment.

The Food and Drug Administration has given tentative approval to Zydus for Macitentan tablets in a dosage strength of 10 mg.

The product is the generic of Actelion Pharmaceuticals’ Opsumit and will be manufactured at CMO Umedica in Vapi, Gujarat.