FDA opts to nail down REMS plan for Sage's land­mark post­par­tum de­pres­sion drug, de­lays fi­nal de­ci­sion

A month be­fore the FDA is sched­uled to hand down what many ex­pect to be an OK for Sage Ther­a­peu­tics’ land­mark drug for post­par­tum de­pres­sion, the agency says it needs some more time to re­view a new­ly sub­mit­ted risk eval­u­a­tion and mit­i­ga­tion strate­gies plan.

The un­ex­pect­ed de­lay push­es its PDU­FA date back three months to March 2019, while the com­mer­cial­iza­tion is now slat­ed to be­gin in June, Sage said in a state­ment, like­ly mean­ing that the REMS will be in place by the time the drug is rolled out.

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