The new lidocaine ointment that Chinese company has declared to the US FDA has been approved. This means that the applicant can produce and sell the product in the US market. It has been determined that the 5% therapeutic effect of lidocaine ointment is equivalent to the original research (RLD) lercaine ointment listed by AstraZeneca. Lidocaine, also known as Xylocaine, is a local anesthetic. It is a derivative of cocaine, but it has no hallucinations and addictive ingredients.
At present, the main manufacturers in the US market include Sandoz, Amneal, Taro, Akorn, and Teligent. The sales of lidocaine ointment in the U.S. market in 2018 were approximately more than 60 million U.S. dollars. At present, there is no import listing of this product in China.
The FDA approval number of lidocaine ointment this time signifies that Chinese companies have the qualifications to sell the product in the U.S. market, and establishes a relevant platform and mechanism for Chinese companies to develop semi-solid preparations and drug administration routes in international businesses. It has a positive impact on the company’s expansion of the US market and improvement of company performance.