Caplin Steriles, a subsidiary of India’s Caplin Point Laboratories, has obtained final approval from the US Food and Drug Administration (FDA) for its generic version of AbbVie’s NIMBEX injection.

The approved drug, Cisatracurium Besylate Injection USP, is expected to be a significant player in a market that, according to IQVIA (IMS Health), generated US sales of approximately $35 million for the 12-month period ending December 2022.

The abbreviated new drug application (ANDA) of Cisatracurium Besylate Injection USP, approved by the FDA, comes in 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). It’s a therapeutic equivalent version of NIMBEX injection produced by AbbVie.

Cisatracurium Besylate Injection USP is a nondepolarizing skeletal neuromuscular blocker. It is used as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgical procedures.

The approval from FDA opens the doors for Caplin Steriles to address a significant medical need in the US market while gaining a slice of a lucrative market segment.

CC Paarthipan — Caplin Point Laboratories Chairman said: “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.”

  AbbVie, Caplin Point Laboratories, Caplin Steriles, CC Paarthipan, US Food and Drug Administration, USA