Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD), Haldol Tablets, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, of Ortho McNeil Pharmaceutical (Ortho McNeil). Haloperidol Tablets are indicated for use in the management of manifestations of psychotic disorders and the control of tics and vocal utterances of Tourette’s Disorder in children and adults.

Haloperidol Tablets, USP, 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg, have an estimated market size of USD 27 million for 12 months ending March 2026, according to IQVIA.

Alembic has a cumulative total of 240 ANDA approvals (221) final approvals and 19 tentative approvals) from US FDA.