Caplin Steriles bags USFDA nod for Etomidate injection

Chennai: Caplin Point Laboratories Limited today announced that Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, 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.

The product is 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 Limited 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.

Mr.C.C.Paarthipan, Chairman of Caplin Point Laboratories Limited commented "We understand Etomidate injection has frequently been on the shortage list in the US, which is probably the reason why we received this approval within 6 months. We hope to launch this product within a short period in the US".

The Company is also working on a portfolio of 35 simple and complex Injectable and Ophthalmic products, to be filed over the next 4 years, with an addressable market size of USD 2.1 Billion.

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