USFDA28 Feb 2026, 12:01 pm
Caplin Steriles Gets USFDA Approval for Desmopressin Acetate Injection
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Desmopressin Acetate Injection USP, 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials. This is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DDAVP (desmopressin acetate) Injection, 4 mcg/mL of Nordic Pharma Inc. The injection is used to treat conditions like haemophilia A, von Willebrand disease, and central diabetes insipidus. According to IQVIA™, the US sales for this injection were approximately $26 million for the 12-month period ending December 2025.
Key Highlights
- Caplin Steriles Limited received final approval from the USFDA for Desmopressin Acetate Injection USP
- The injection is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DDAVP
- The injection is used to treat conditions like haemophilia A, von Willebrand disease, and central diabetes insipidus
- According to IQVIA™, the US sales for this injection were approximately $26 million for the 12-month period ending December 2025