Since June, a number of pharmaceutical products have been approved by the US FDA

[pharmaceutical Station industry trends] with the rapid development of the domestic pharmaceutical industry, more and more pharmaceutical companies begin to put their goals far away and invest in overseas markets Many pharmaceutical companies have the qualification to sell products in the U.S market by obtaining the approval number of the U.S FDA, which has a positive impact on the company's expansion of the U.S generic drug market According to the public information, the author sorted out the drug companies that have obtained the approval number of FDA since June Humanwell: niacin sustained-release tablets on June 15, humanwell pharmaceutical released a notice on the approval number of niacin sustained-release tablets from the US FDA The announcement shows that Nicotinic Acid Sustained Release Tablets is used to reduce the incidence rate of myocardial infarction caused by inherited hyperlipidemia Combined medication can reduce the incidence rate of primary diseases and assist the adults with severe hypertriglyceridemia According to IMS data statistics, the total sales volume of niacin sustained-release tablets in the U.S market in 2018 is about 36 million US dollars According to the data statistics of minenet, in 2017, the sales volume of all nicotinic acid dosage forms in the three terminal public hospitals and retail terminals of cities, counties and towns in China was about 7.5 million yuan Yichang humanwell submitted the Anda application for niacin sustained release tablets in 2018, with a cumulative R & D investment of about 10 million yuan Huahai Pharmaceutical Co., Ltd.: on the same day, Huahai Pharmaceutical Co., Ltd issued a notice on the approval number of the preparation product potassium chloride sustained release capsule obtained from the US FDA According to the announcement, potassium chloride sustained-release capsule is mainly used to treat hypokalemia caused by various reasons Potassium chloride sustained-release capsules were launched in the United States in 1982 At present, there is no product of this dosage form on the market in China In 2018, the sales volume of the drug in the U.S market was about 48 million US dollars Up to now, the company has invested about 8.5 million yuan in the research and development of potassium chloride sustained release capsule project Jingfeng pharmaceutical: methylprednisolone tablets on June 28, Jingfeng pharmaceutical issued a notice on the approval number of the subsidiary drugs obtained from the US anda, and its subsidiary companies received the notice from the US FDA, and the application for the simplified new drug anda of methylprednisolone tablets which has been declared to the US FDA has been approved According to the announcement, methylprednisolone tablets will be used for some rheumatic diseases, collagen diseases, skin diseases, allergic diseases, eye diseases, respiratory diseases, blood diseases, tumors, edema, gastrointestinal diseases, nervous system diseases, organ transplantation, etc According to IMS data, the annual sales volume of methylprednisolone tablets (4mg) in the U.S market as of the first quarter of 2019 is about US $93 million, and the sales volume in the U.S market in 2018 and 2017 are US $113 million and US $124 million, respectively Puli pharmaceutical: vancomycin hydrochloride for injection on June 13, Puli pharmaceutical released the announcement that vancomycin hydrochloride for injection has obtained the FDA registration approval According to the announcement, vancomycin was first developed by Lilly and approved by FDA in 1958 Vancomycin hydrochloride for injection of the company submitted an application for marketing license to FDA in July 2018, with specifications of 500mg and 1g, and recently received the approval notice from FDA of the United States Shuangcheng Pharmaceutical Co., Ltd.: bivalirudin for injection Shuangcheng Pharmaceutical Co., Ltd recently announced that the company has submitted an application for approval of the generic drug bivalirudin for injection to the US FDA The company said that the success of the challenge will enable the company's developed generic product bevaludine for injection to be marketed in the United States before the expiration of the original research drug (valid until January 27, 2029), laying an important foundation for the subsequent registration and sale of generic drugs in the United States Fosun medicine: Orin 1001 June 16, Fosun medicine announced that the US FDA has recently granted its new drug Orin 1001 a fast channel qualification for the treatment of recurrent, refractory and metastatic breast cancer (including triple negative breast cancer) This shows that the R & D and internationalization of Fosun Pharmaceutical are entering a new stage According to the announcement, as of May 2019, Fosun Pharmaceutical Group has invested about 45.47 million yuan in research and development of the new drug.