Caplin Steriles receives USFDA approval for Etomidate injection

Caplin Point Laboratories announced that Caplin Steriles, a Subsidiary Company, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Etomidate injection USP, 20 mg/10 ml (2 mg/ml) and 40 mg/20 ml (2 mg/ml) Single-dose vial presentations, a generic therapeutic equivalent version of (RLD), AMIDATE (Etomidate) Injection, of HOSPIRA INC.

According to IQVIA (IMS Health), Etomidate injection USP had US sales data of approximately $9 million for the 12- month period ending Oct 2020.

Caplin Steriles, has developed and filed 19 ANDAs on its own and with partners, with 11 approvals so far. Etomidate is a general anesthetic, used for the induction of general anesthesia and for the supplementation of subpotent anesthetic agents.

 

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