FDA Approves New Dosing for Abortion Pill

March 31, 2016

On Wednesday, March 30th, FDA approved a new label for Mifeprex® (mifepristone), the medical abortion pill. The FDA stated that the drug is both safe and effective when taken in lower doses and up to 70 days after a woman’s last period.

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 states that it is still necessary to have a REMS program for Mifeprex in order to ensure that the product is used safely.

Are you developing an sNDA or other FDA regulatory submission? We can help. To learn more about our services and how we can help you get through FDA, contact us today.

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