Alembic Pharma gets tentative USFDA nod for Brexpiprazole tablets

The drug maker on Thursday announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Brexpiprazole tablets.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti tablets.

Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for treatment of schizophrenia. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

According to IQVIA, Brexpiprazole Tablets have an estimated market size of $1.6 billion for twelve months ending December 2022.

The pharma company said that it has a cumulative total of 184 ANDA approvals (160 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.

The drug maker reported 29% drop in consolidated net profit to Rs 121.92 crore despite a 18.7% rise in net sales to Rs 1509.02 crore in Q3 FY23 over Q3 FY22.

Shares of Alembic Pharmaceuticals were up 0.36% to Rs 514.15 on the BSE.

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