Alembic Pharma gets USFDA nod for Haloperidol Tablets

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Haloperidol Tablets, USP, in strengths of 1 mg, 2 mg, 5 mg, 10 mg, and 20 mg. This approval makes the product therapeutically equivalent to the reference listed drug, Haldol Tablets. Haloperidol Tablets are used for managing psychotic disorders and Tourette's Disorder. The estimated market size for these tablets is US$ 27 million. This marks Alembic's 221st final ANDA approval from the USFDA, contributing to their total of 240 approvals.