Corporate News     12-Jun-23
Caplin Steriles receives USFDA approval for Cisatracurium Besylate 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) Cisatracurium Besylate Injection USP, 10 mg/5 mL (2 mg/mL) and 200 mg/20 mL (10 mg/mL) Single-dose Vials; and 20 mg/10 mL (2 mg/mL) Multiple-dose Vials (Preserved)., a generic therapeutic equivalent version of (RLD), NIMBEX injection of AbbVie Inc.

Cisatracurium Besylate Injection USP is a nondepolarizing skeletal neuromuscular blocker, indicated as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgical procedures. According to IQVIATM (IMS Health), Cisatracurium Besylate Injection USP had US sales of approximately $35 million for the 12-month period ending December 2022.

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