USFDA14 May 2025, 11:06 am
Caplin Point's Subsidiary, Caplin Steriles, Receives USFDA Approval for Haloperidol Decanoate Injection
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has been granted final approval from the USFDA for its ANDA Haloperidol Decanoate Injection. The injection is a generic therapeutic equivalent version of the RLD HALDOL (haloperidol decanoate) Injection by Janssen Pharmaceuticals Inc. The injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. According to IQVIA™, Haloperidol Decanoate Injection had US sales of approximately $16.4 million for the 12-month period ending March 2025.
Key Highlights
- Caplin Steriles Limited receives USFDA approval for Haloperidol Decanoate Injection
- The injection is a generic therapeutic equivalent version of the RLD HALDOL (haloperidol decanoate) Injection by Janssen Pharmaceuticals Inc.
- The injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
- Haloperidol Decanoate Injection had US sales of approximately $16.4 million for the 12-month period ending March 2025