Last Updated on October 17, 2024 by The Health Master
Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) 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.
A neuromuscular blocking agent called rocuronium bromide injection is recommended as a supplement to general anesthesia to ease routine and rapid sequence tracheal intubation as well as to relax skeletal muscles during surgery or mechanical ventilation.
According to IQVIA (IMS Health), Rocuronium Bromide Injection had US sales of approximately $53 million for the 12-month period ending September 2022.
“This is an important product in our anesthesia portfolio for global markets, and we look forward to launching it in the US in the coming months,” said CC Paarthipan, Chairman of Caplin Point Laboratories.
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