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Viwit Lidocaine Hydrochloride Injection Officially Approved in the U.S.
Author：
VIWIT
Release Time：
2026-03-23
Recently, Viwit’s Lidocaine Hydrochloride Injection received an Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA), officially authorizing its launch in the U.S. market.
Indications:
Lidocaine Hydrochloride Injection contains lidocaine, an amide local anesthetic. Lidocaine Hydrochloride Injection is indicated in adult and pediatric patients for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. For each type of block indicated to produce local or regional anesthesia or analgesia, specific concentrations and presentations are recommended.
Different Strengths for Safety and Convenience:
1% [300 mg/30 mL (10 mg/mL)] MPF Single-Dose Vials
2% [100 mg/5 mL (20 mg/mL)] MPF Single-Dose Vials
2% [400 mg/20 mL (20 mg/mL)] Multiple-Dose Vials
The approved products include both methylparaben-free single-dose and multiple-dose vials in different strengths, better meeting clinical needs across different scenarios, enhancing safety and convenience, and offering strong market adaptability and competitive potential.
Global Expansion Steadily Advancing:
Previously, National Medical Products Administration (NMPA) approved the Consistency Evaluation of the Quality and Efficacy of Lidocaine Hydrochloride Injection (5 ml:0.1 g) for local anesthesia and antiarrhythmic use in China. We look forward to benefiting more patients worldwide, providing safe and effective options for surgical anesthesia, analgesia, and arrhythmia treatment, and contributing to improved healthcare quality and patient outcomes.
This FDA ANDA APPROVAL not only demonstrates Viwit’s comprehensive strength in drug R&D, manufacturing quality, and international registration but also marks a solid step forward in the Viwit’s globalization strategy. Successful entry into the U.S. market will further enhance the Viwit’s brand influence.
In the future, Viwit Pharmaceuticals will continue to uphold its mission of “Innovation for a Better Life,” actively advancing product registration and launch in more countries and regions, and delivering high-quality, accessible medical solutions to patients globally.