USFDA nod to Caplin Steriles Cisatracurium Besylate Injection
Chennai: Caplin Steriles Limited, a Subsidiary company of Caplin Point Laboratories Limited, has been granted final approval by 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).
The product is 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 IQVIA (IMS Health), Cisatracurium Besylate Injection USP had US sales of approximately $35 million for the 12- month period ending December 2022.
C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented, “We’ve been consistent with our filings and also happy to receive approvals on time. We’re creating a healthy portfolio of products that we will launch not only in the US but in global markets as well. This approval will augment our growth plans for Caplin Steriles this year and the years going forward.”
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