New specification supplement application of doxycycline hydrochloride sustained release tablets of Huahai Pharmaceutical Co., Ltd. approved by FDA

Today, Huahai pharmaceutical announced that recently, the company received a notice from the FDA of the United States, and the supplementary application for the new specifications of doxycycline hydrochloride sustained-release tablets declared by the company to the FDA of the United States has been approved Doxycycline hydrochloride sustained-release tablet is a broad-spectrum antibiotic of tetracycline The original drug of doxycycline hydrochloride sustained-release tablets was developed by mayneparma company, and was approved to be listed in the United States as early as 2008 At present, in the United States, the manufacturers of doxycycline hydrochloride sustained-release tablets are mylan, heritage, solcohealthcare; doxycycline is commonly used in China, and the approved dosage forms are tablet, capsule, injection and other dosage forms, the manufacturers are mainly Jiangsu Lianhuan Pharmaceutical Co., Ltd., Haikou Qili Pharmaceutical Co., Ltd., etc., but there is no sustained-release tablet in China Tablet type approved for sale According to IMS database, the sales volume of doxycycline hydrochloride sustained-release tablets in the U.S market in 2018 was about US $31.7094 million; the sales volume of doxycycline (doxycycline) preparation products (including all approved dosage forms) in domestic hospitals in 2017 was about RMB 96.49 million (data from Xianda database) The following is the original announcement: