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Tag: first to file

Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.

Posted on October 7, 2026 By admin
Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.

Granules India seeks first mover advantage | Photo Credit: The Hindu Generic drugmaker Granules India has filed a Paragraph IV certification with the U.S. Food and Drug Administration (U.S. FDA) in connection with its abbreviated new drug application (ANDA) for Ruxolitinib Extended-Release Tablets. Based on the timing and status of its ANDA and Paragraph IV…

Read More “Granules eyes first to file status, 180 days exclusivity on generic cancer drug Ruxolitinib in U.S.” »

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