Alembic Pharmaceuticals Gains USFDA Nod for Generic Macitentan
Alembic Pharmaceuticals Ltd has received final approval from the USFDA for its generic Macitentan tablets, used for treating pulmonary arterial hypertension. The approval allows the company to market its 10 mg tablets as equivalent to Actelion's Opsumit. The market size is estimated at USD 1,180 million by mid-2025.
- Country:
- India
Alembic Pharmaceuticals Ltd announced on Tuesday that it has secured final approval from the United States Food and Drug Administration (USFDA) for its generic version of Macitentan tablets.
This medication is indicated for the management of pulmonary arterial hypertension (PAH), a condition marked by elevated blood pressure in the arteries of the lungs, in order to reduce progression risks and hospitalizations.
The approved abbreviated new drug application (ANDA) for 10 mg Macitentan tablets positions Alembic's product as therapeutically equivalent to the reference drug Opsumit, manufactured by Actelion Pharmaceuticals US. Market data positions the product's potential at a valuation of USD 1,180 million by June 2025.
(With inputs from agencies.)
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- Alembic
- Pharmaceuticals
- USFDA
- Macitentan
- PAH
- generic
- approval
- market
- Opsumit
- Actelion
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