healthcareandpharma (3)

1
Questions and answers on the FDA approved drug
Mifeprex

• https//www.safeabortionpharma.com

2
Mifeprex What is it and how does it work?

• Mifeprex 200 Mg (mifepristone) is a medication
  that inhibits the production of a hormone called
  progesterone, which is required for a pregnancy
  to proceed. Mifeprex is used to terminate an
  early pregnancy when combined with another
  medication called misoprostol (12 weeks or less
  since the first day of the last menstrual
  period).

3
What revisions did FDA approve last on the
Mifeprex application?

• Mifeprex pills online were approved by the FDA
  for the first time in 2000. The FDA approved a
  supplementary application submitted by the
  biopharmaceutical company that markets Mifeprex
  in 2016. This approval included changes to the
  Mifeprex dose and the Mifeprex and misoprostol
  dosing regimen (including the misoprostol dose
  and a change in the route of misoprostol
  administration from oral to buccal (in the cheek
  pouch), the interval between taking Mifeprex and
  misoprostol, and the location at which the woman
  may take misoprostol.

4

• The approval also changed the gestational age at
  which Mifeprex has been proved to be safe and
  effective. Furthermore, the labeling was changed
  to satisfy the FDA's current labeling criteria.
  The FDA also approved revisions to the current
  Risk Evaluation and Mitigation Strategy (REMS) to
  reflect the changes allowed in the additional
  application and to align the Mifeprex REMS with
  more recently approved REMS.

5

• Notably, the FDA granted a supplemental
  application for Mifeprex on April 11, 2019,
  authorizing modifications to the existing
  approved REMS for Mifeprex in order to establish
  a single, shared system REMS for mifepristone
  products (including Mifeprex and the approved
  generic version of Mifeprex) for the medical
  termination of intrauterine pregnancy through 84
  days gestation.

6
Thank you