BRIEF—Tentative FDA nod for Zydus' macitentan tablets

Zydus Worldwide DMCC, a wholly-owned subsidiary of Indian generic drugmaker Cadila Healthcare, has received tentative approval from the US Food and Drug Administration to market its generic drug macitentan tablets in the USA.

Macitentan is the active ingredient of Opsumit, which was developed and marketed by Acelion Pharmaceuticals, which is now part of US healthcare giant Johnson & Johnson.

The medication is indicated for the treatment of pulmonary arterial hypertension.

The drug will be manufactured at contract manufacturing organization (CMO) Umedica Laboratories Pvt in Vapi, Gujarat, said Zydus.

The FDA delays full approval of a generic product until all patent or exclusivity issues have been resolved.