Jiangsu Hengrui Pharmaceuticals (600276.SH) announced on July 2 that the company has received a notification from the U.S. Food and Drug Administration (FDA) that the company's ANDA (abbreviated new drug application, i.e. generic drug application) for Bupivacaine Liposome Injection has been approved, making it the first manufacturer to obtain approval for this generic drug type in the United States.
Bupivacaine is an amide local anesthetic widely used in clinical practice for local anesthesia and postoperative analgesia. Compared to the 5-6 hour duration of conventional injections, Bupivacaine Liposome Injection can extend the analgesic effect to several days. It uses an advanced multipolymer liposomal drug delivery system, which has a good sustained release effect and is more conducive to pain management in surgical patients, thereby improving the quality of life of patients.