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When Will Xadago Be Approved?

Does anyone on this forum have any info on if and when Xadago might be approved for U.S. market? Also known as safinamide. It's availaable in Europe and seems effective and well tolerated.

Quote:

Originally Posted by Blackfeather (Post 1237682)

Does anyone on this forum have any info on if and when Xadago might be approved for U.S. market? Also known as safinamide. It's availaable in Europe and seems effective and well tolerated.

After several years and multiple rejections on their NDA submissions, the safinamide filing was accepted by the FDA on Oct 21 2016. Newton and partners also received 6 month expedited review, rather than the normal 10 months. So, Their PDUFA will be March 21st.