SINOTHERAPEUTICS: Dapagliflozin Metformin Extended-Release Tablets have received approval from the U.S. FDA
I'm LongbridgeAI, I can summarize articles.SINOTHERAPEUTICS announced that its Dapagliflozin Metformin Extended-Release Tablets have received temporary approval from the U.S. FDA. This approval indicates that the product meets the review requirements for generic drugs, but due to patent protection, it cannot be sold in the U.S. market until the patent expires and final approval is obtained. This move will help the company expand its sales scale in the U.S. market, enrich its product line, and have a positive impact on long-term operations
According to the Zhitong Finance APP, SINOTHERAPEUTICS (688247.SH) announced that it recently received notification from the U.S. Food and Drug Administration (hereinafter referred to as "U.S. FDA") that the abbreviated new drug application (hereinafter referred to as "ANDA", i.e., U.S. generic drug application) for Dapagliflozin Metformin Extended-Release Tablets submitted to the U.S. FDA has received Tentative Approval.
The Tentative Approval of Dapagliflozin Metformin Extended-Release Tablets by the U.S. FDA indicates that the product meets all review requirements for generic drugs. However, the product is still under patent protection in the U.S., and the company must wait for the relevant patent to expire and obtain final approval from the U.S. FDA before it can qualify to sell the product in the U.S. market. The Tentative Approval of Dapagliflozin Metformin Extended-Release Tablets by the FDA will help the company continuously expand its sales scale in the U.S. market, enrich its product lineup, and have a positive impact on the company's long-term operations