Photo taken on Aug. 23, 2021 shows the U.S. Food and Drug Administration in Silver Spring, Maryland, the United States. (Photo by Ting Shen/Xinhua)
BEIJING, April 15 (Xinhua) -- Zhejiang Huahai Pharmaceutical Co., Ltd. (Huahai Pharmaceutical, 600521.SH) announced on Wednesday that its Abbreviated New Drug Application (ANDA) for Apixaban Tablets submitted to the U.S. Food and Drug Administration (FDA) has been temporarily approved, reported China Securities Journal.
This indicates that this drug has passed all the review requirements of generic drugs, but it will notbe sold in the U.S. market untilthe patent right expires and FDA gives the final approval.
It is reported that Apixaban Tablets are mainly used to reduce the risk of stroke and systemic embolism.
Apixaban Tablets were developed by U.S. firm BMS and launched in the United States in January 2013. At present, only the original research product is available in the U.S. market because it is still in the patent protection period.
According to IMS database data, the sales of Apixaban Tablets in the U.S. market in 2021 was about 15.823 billion U.S. dollars.
(Edited by Zhang Yao, Gu Shanshan with Xinhua Silk Road, gushanshan.1987@163.com)
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