Levetiracetam, a new class 3.1 antiepileptic drug of xinlitai, entered the site for examination this month

According to the website of the State Food and Drug Administration (CFDA) on March 11, the 3.1 chemical drug zuelacetan APIs and tablets declared by Shenzhen xinlitai Pharmaceutical Co., Ltd entered the production site for inspection this month At present, only the original research drug levetiracetam tablets and oral solutions are on sale in China, and there is no domestic enterprise to produce the product According to the new drug review process, entering the production site for inspection is the last inspection link of the drug application for approval and production Subsequently, there are procedures such as forming the review conclusion, transferring the report to the drug review center and submitting it to the Drug Administration for signature If there is no accident, xinlitai is expected to obtain the production approval document of the product in the second half of this year Insiders have said the product is of great significance to the company Xinlitai is mainly engaged in R & D and sales of cardiovascular chemicals, among which, the first generic drug "Taijia" (clopidogrel tablets), which accounts for 40% of the company's revenue, has been repeatedly used by competitors in bidding, and the market is worried that Taijia's current market share may decline; and xinlitai's subsequent reserve varieties echelon has become a major concern of the market This is expected to become the first domestic imitation of levetiracetam tablet, which is mainly used for the treatment of localized and secondary systemic epilepsy It is an antiepileptic drug The original research drug is Kaplan of Belgium United Chemical Enterprise (UCB S.A.) As one of UCB's top products, Kaplan was approved by FDA in April 2000, listed in the United States and the European Union, and listed in China in 2011 At present, the product has been on the market in more than 66 countries and regions, and it is the most widely used new antiepileptic drug in the United States IMS data shows that in 2008, the global average annual sales of Kaplan was about 1.2 billion US dollars According to CFDA information, levetiracetam will be intensively inspected on site this month In addition to xinlitai, Beijing New Pharmaceutical Co., Ltd and levetiracetam declared by Chongqing shenghuaxi Pharmaceutical Co., Ltd will also be inspected on site this month, but only the API, not the preparation.