Caplin receives USFDA approval for Desmopressin Acetate Injection

Caplin Steriles (Caplin), a Subsidiary Company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (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, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DDAVP (desmopressin acetate) Injection, 4 mcg/mL of Nordic Pharma Inc., (NDA 018938).

Desmopressin Acetate Injection is used to treat conditions like haemophilia A, von Willebrand disease, and central diabetes insipidus, helping to manage bleeding and regulate urine production. According to IQVIATM (IMS Health), Desmopressin Acetate injection USP, 4 mcg/mL single-dose vials and 40 mcg/10 mL (4 mcg/mL) multiple-dose vials had US sales of approximately $26 million for the 12-month period ending December 2025.

 

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