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Two REMS, Two Names, One Drug: Is It Safe? FDA Questions Jazz's Proposal For Fibromyalgia Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

Advisory panel on sodium oxybate will weigh whether separate REMS for Xyrem and proposed Rekinla can prevent medication errors and abuse.

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Corcept’s NDA for the controversial agent mifepristone in Cushing’s syndrome required that FDA balance the needs of prospective patients with a severe orphan disease with the desire to preserve the drug’s REMS for abortifacient use as Mifeprex. FDA’s decision to forgo a REMS was grounded on principle, precedent, and assessment of real-world likelihood of off-label use – and vetted all the way to the CDER director.

FDA’s Decision To Back Off Korlym REMS Shows Context Is King

Corcept’s NDA for the controversial agent mifepristone in Cushing’s syndrome required that FDA balance the needs of prospective patients with a severe orphan disease with the desire to preserve the drug’s REMS for abortifacient use as Mifeprex. FDA’s decision to forgo a REMS was grounded on principle, precedent, and assessment of real-world likelihood of off-label use – and vetted all the way to the CDER director.

Warning Letter On Adverse Event Reporting May Stem As Much From Jazz Reaction As REMS Problem

Jazz Pharmaceuticals initially admitted it had known about 10 deaths and 64 other serious, unexpected adverse drug experiences associated with its cataplexy drug Xyrem, but later changed its story, FDA says.

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