NEW DELHI, Mar 14:
Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market Macitentan tablets, which is used to treat high blood pressure, in the American market.
The company said it has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Macitentan tablets, 10 mg.
The tentatively approved ANDA is therapeutically equivalent to the Actelion Pharmaceuticals US, Inc’s Opsumit Tablets, 10 mg, which are indicated for the treatment of pulmonary arterial hypertension.
As per IQVIA, Macitentan tablets had an estimated market size of USD 797 million for 12 months ending December 2021.
The drug firm said it has received 22 approvals in the year-to-date (YTD) period and has cumulative total of 161 ANDA approvals so far from the USFDA. (PTI)
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