REYVOW

批准信原文要点

Removal of the recommendation… to avoid concomitant use… with… P-gp and BCRP substrates. • Addition… coadministration… with P-gp substrates where a small change… may lead to serious toxicities is not recommended. • Revisions in… 12.3…

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for the addition of Pregnancy Exposure Registry information in the Use in Specific Populations (8.1) and Patient Counseling Information (17) sections of the Prescribing Information and in the Medication Guide.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the currently registered manufacturing process including the following: APPROVAL(b) (4)(b) (4)(b) (4) We have completed our review of this supplemental application.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for the addition of a new adverse reaction, ‘feeling hot or feeling cold’, to Section 6.1 (Adverse Reactions; Clinical Trials Experience [Less Common Adverse Events]).

批准信原文要点

This “Changes Being Effected” sNDA provides for inclusion of the controlled substance symbol and Initial U.S. Approval date into labeling based on the Federal Register notice of the interim final rule for the placement of lasmiditan in Schedule V.