FDA Approves Mesalamine Delayed–Release Tablets, Generic of Lialda, for UC

FDA Approves Mesalamine Delayed–Release Tablets, Generic of Lialda, for UC
The U.S. Food and Drug Administration (FDA) has given final approval for Zydus Cadila to market Mesalamine Delayed–Release Tablets USP, a generic version of Lialda, in the U.S. to treat ulcerative colitis (UC).

The announcement follows news in May that Zydus had won a court battle over Shire’s patent for Lialda. The U.S. Court of Appeals for the Federal Circuit ruled that Zydus’ proposed generic version of Lialda does not infringe upon Shire’s patent covering the drug.

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