Caplin Steriles Gets USFDA Nod For Schizophrenia Drug Haloperidol Decanoate

Caplin Laboratories Ltd. on Wednesday said its subsidiary Caplin Steriles Ltd. has received final approval from the US Food and Drug Administration for haloperidol decanoate injection, according to an exchange filing.

The product will be available in 50 mg/mL and 100 mg/mL single-dose vials, and a 500 mg/5 mL multi-dose vial.
 
Haloperidol decanoate is a bioequivalent of Haldol injection by Janssen Pharmaceuticals Inc. and is used for treating schizophrenia requiring long-term parenteral antipsychotic therapy. The drug had sales of about $16.4 million in the US for the year ended March, the company said.