Mifeprex, the branded product for mifepristone, was originally approved by the FDA in 2000. The drug was approved to abort a pregnancy when taken in combination with misoprostol within 49 days of a woman’s last period. Mifepristone works by blocking the necessary hormones, and is administered with misoprostol, which is used to induce contractions to start what many women compare to a heavy period. The product’s original labeling specified a dose of 600 mg, but as doctors figured out that they could achieve the same results with a much lower dose and fewer side effects, many doctors began prescribing mifepristone at a dose of just 200 mg.
In May 2015, Danco Laboratories, manufacturer of Mifeprex, submitted a supplemental new drug application (sNDA) to FDA for a 200 mg dose of the drug. Earlier this week, the FDA approved the sNDA. In addition to a lower dose of the drug, the approved sNDA also prolongs the period of time in which it can be used, extending it from 49 days after a woman’s last menstrual period to 70 days.
FDA Extends Compliance Date For GUDID For Some Devices After Discovering Security Flaw
In 2013, FDA introduced a new set of regulations that would establish a unique device identification system for medical devices. They also announced the dates for implementation, which would be done...