Liva gets FDA nod for generic Haldol

Liva Pharmaceuticals, a subsidiary of Cadila Healthcare, has received the Food and Drug Administration’s approval for haloperidol decanoate injection, in dosage strengths of 50 mg (base)/mL and 100 mg (base)/mL, single-dose vials, 250 mg (base)/5 mL (50 mg (base)/mL) and 500 mg (base)/5 mL (100 mg (base)/mL), multiple-dose vials.

Haloperidol is used in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette syndrome.

It is the generic of McNeil Laboratories’ Haldol decanoate injection, 50 mg (base)/mL and 100 mg (base)/mL).

The product will be manufactured at Liva Pharma’s manufacturing facility at Vadodara.