Caplin Steriles (Caplin), a subsidiary of Caplin Point Laboratories, has received final FDA approval for its Abbreviated New Drug Application (ANDA) Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL Multi-dose Vials, a generic therapeutic equivalent version of (RLD), ZEMURON Injection, of Organon USA Inc.
Rocuronium Bromide Injection is a neuromuscular blocking agent used as an adjunct to general anaesthesia to facilitate rapid sequence and routine tracheal intubation, as well as to relax skeletal muscles during surgery or mechanical ventilation. Rocuronium Bromide Injection had US sales of approximately $53 million for the 12-month period ending September 2022, according to IQVIATM (IMS Health).