Alembic Pharmaceuticals receives USFDA approval for Macitentan Tablets

20 Mar 2022 , 01:33 AM

Alembic Pharmaceuticals today announced that it has received tentative approval from the US Food Drug Administration USFDA for its Abbreviated New Drug Application ANDA for Macitentan Tablets 10 mg The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product RLD Opsumit Tablets 10 mg of Actelion Pharmaceuticals US Inc Actelion Macitentan Tablets are an endothelin receptor antagonist ERA indicated for the treatment of pulmonary arterial hypertension PAH WHO Group I to delay disease progression Disease progression included death initiation of intravenous IV 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 reduced hospitalization for PAH It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses Macitentan Tablets 10 mg have an estimated market size of US$ 797 million for twelve months ending Dec 2021 according to IQVIA Alembic has received year to date YTD 22 approvals 15 final approvals and 7 tentative approvals and a cumulative total of 161 ANDA approvals 138 final approvals and 23 tentative approvals from USFDA