Mifeprex Approved for Use Through 70 Days Gestation
The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Mifeprex (mifepristone; Danco Laboratories) including modifications to the risk evaluation and mitigation strategy (REMS) assessment.
The sNDA proposed use of Mifeprex through 70 days gestation with revisions to the labeled dose and dosing regimen. The updated drug labeling now states that Mifeprex is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation; it was previously approved only through Day 49 of pregnancy. The new dosing regimen is as follows: Mifeprex 200mg orally on Day 1, followed 24–48 hours after Mifeprex dosing by misoprostol 800mcg buccally. Additional data on post-treatment assessment (Days 7–14) has also been modified.
Also, under the Warnings and Precautions section, it states that women who became pregnant with an intrauterine device in place should be assessed for ectopic pregnancy.
The REMS for Mifeprex, initially approved in June 2011, consisted of a Medication Guide, elements to assure safe use, an implementation system, and a timetable for submission of assessment of the REMS. The proposed modifications included revisions to both the prescriber and patient agreement forms. The current program was also reviewed to determine whether each REMS element remained necessary to ensure that the drug's benefits outweighed the risks. The FDA determined that it is no longer necessary to include the Medication Guide as part of the approved REMS.
The modified REMS will now consist of elements to assure safe use, an implementation system and a timetable for submission of REMS assessment.
Mifeprex, a progestin antagonist, is available as 200mg tablets in 3-count single-dose packs.
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