China’s Jiangsu Hengrui First to Market Generic Exparel in the US with FDA ANDA Approval

Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first company to launch a generic version of the drug in the U.S.

Bupivacaine liposome, an amide-based local anesthetic, is extensively used in clinical settings for local anesthesia and postoperative analgesia. Unlike conventional injections that provide relief for approximately 5 to 6 hours, this drug can extend the analgesic effect to several days. Its advanced multicellular liposome drug delivery system allows for a sustained-release effect, which is particularly beneficial for pain management in surgical patients and can significantly improve their quality of life. The originator product is currently only available in the U.S. and Europe.- Flcube.com

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