Alembic receives FDA tentative nod for generic Opsumit

The Food and Drug Administration has given Alembic tentative approval for macitentan tablets in a dosage strength of 10 mg.

The medication is the generic of Actelion’s Opsumit tablets.

[Read more: Alembic launches generic Anafranil]

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, which includes death, initiation of intravenous or subcutaneous prostanoids or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). 

Macitentan tablets also reduce hospitalization for PAH. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses, the company said.

[Read more: Alembic obtains FDA nod for 2 generics]

Macitentan tablets have a market value of roughly $797 million for the12 months ending Dec 2021, according to IQVIA.