India, May 14 -- Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Ltd has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Haloperidol Decanoate Injection.
The approved product includes 50mg/mL and 100mg/mL single-dose vials, as well as 500mg/5mL (100mg/mL) multiple-dose vials. It is a generic therapeutic equivalent of HALDOL (haloperidol decanoate) Injection, originally developed by Janssen Pharmaceuticals Inc, the company said in a BSE filing.
Haloperidol Decanoate Injection is indicated for patients with schizophrenia who require long-term parenteral antipsychotic treatment. As per IQVIA (IMS Health), the U.S. market for this drug ...