Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy

Caplin Steriles Limited (Caplin), a subsidiary company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Haloperidol Decanoate Injection, 50mg/mL and 100mg/mL Single Dose Vials; 500mg/5mL (100mg/mL) Multiple-Dose Vials, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) HALDOL (haloperidol decanoate) Injection, by Janssen Pharmaceuticals Inc.

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. According to IQVIA (IMS Health), Haloperidol Decanoate Injection had US sales of approximately $16.4 million for the 12-month period ending March 2025.