Alembic Pharmaceuticals receives USFDA approval for Haloperidol Tablets

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) 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 product (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: i) use in the management of manifestations of psychotic disorders and ii) the control of tics and vocal utterances of Tourette's Disorder in children and adults. Refer label for a detailed indication.