A nova pomada de lidocaína que a empresa chinesa declarou ao FDA dos EUA foi aprovada. Isto significa que o requerente pode produzir e vender o produto no mercado dos EUA. Determinou-se que o 5% efeito terapêutico da pomada de lidocaína é equivalente à pesquisa original (RLD) pomada de lercaína listada pela AstraZeneca. Lidocaína, também conhecido como xilocaína, 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.