Lupin Launches Generic Rocuronium Bromide Injection Following U.S. FDA Approval

Lupin today announced the launch of Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Multiple-Dose Vials after Lupin’s alliance partner Caplin Steriles Limited (Caplin) received approval for its ANDA from the United States Food and Drug Administration (U.S. FDA), the company informed in an exchange filing on Wednesday.

Rocuronium Bromide Injection 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Multiple-Dose Vials is the generic version of Zemuron Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA, and is indicated for inpatients and outpatients as an adjunct to general anaesthesia to facilitate both rapid sequence and routine tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, the company added.

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the U.S. according to IQVIA MAT, August 2023, the statement from the company read.