Xuantai medicine mesalazine enteric-coated tablets listed in the United States

Recently, the generic MESALAMINE (delayed-releasetablets,1.2g) developed by Xuantai Pharmaceutical has been approved by the US Food and Drug Administration (FDA) (ANDA217337).

MESALAMINE enteric-coated tablets

Mesalazine is a first-line drug for induction therapy and maintenance of remission in mild to moderate ulcerative colitis, which can inhibit the activation of various inflammatory cells in the intestine and protect the intestinal mucosa from damage. A variety of mesalazine formulations with different dosage forms and specifications have been marketed worldwide, among which mesalazine enteric-coated tablets (1.2g) need to be taken only once a day, which can improve patient compliance and has certain technical development barriers. Mesalazine enteric-coated tablets (1.2g) have sold nearly 200 million tablets in the United States, with sales of about 600 million US dollars, accounting for more than 40% of the overall mesalazine preparation market share. The main manufacturers are Takeda,Zydus, etc.

Xuantai Pharma has submitted an ANDA application for this product to the China Food and Drug Administration in July 2022, and it is currently under review and approval.