FDA approves antipsychotic haloperidol injection, USP

September 9, 2011

FDA has approved an antipsychotic medication, haloperidol injection, USP (Sagent Pharmaceuticals), indicated for use in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.

FDA has approved an antipsychotic medication, haloperidol injection, USP (Sagent Pharmaceuticals), indicated for use in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.

Haloperidol will be offered in 5 mg/mL single-dose and 50 mg/10 mL multi-dose, latex-free vials.

According to 2011 IMS data, the annual U.S. injectable market for haloperidol approximated $12.5 million.

As with all products in Sagent's portfolio, haloperidol features the company's PreventIV Measures packaging and labeling, designed to aid in the reduction of medication errors.

Sagent expects to launch the product early in the fourth quarter.