FDA Approves New Label for Lower Dose of Abortion Drug

Regulatory NewsRegulatory News | 30 March 2016 |  By 

In a win for public health advocates, the US Food and Drug Administration (FDA) on Wednesday approved new labeling for the abortion drug Mifeprex (mifepristone), supporting its safety and effectiveness when taken at lower doses and later in pregnancy.

FDA first approved mifepristone in 2000 as a 600mg dose to end a pregnancy within 49 days of a woman's last menstrual period when taken in combination with misoprostol. However, even before mifepristone was approved, studies found that a 200mg dose of the drug was effective in ending pregnancy.

Despite mifepristone's original labeling, most doctors used mifepristone off-label at the lower dose.

However, FDA approved a supplemental new drug application (sNDA) supporting the 200gm dose of the drug, and extended the period of time it can be used by three weeks, from 49 days after a woman's last menstruation to 70 days. Additionally, the new labelling makes changes to the route of administration and dose of misoprostol.

FDA notes that a risk evaluation and mitigation strategy (REMS) is still necessary "to ensure the safe use of Mifeprex."


Physician groups and reproductive health advocates have praised FDA for approving mifepristone's new label.

The American Congress of Obstetricians and Gynecologists said in a statement that it's "pleased that the updated FDA-approval regimen for mifepristone reflects the current available scientific evidence and best practices … extending approved use of mifepristone through 70 days of gestation is proven to be safe and effective, and will give women more time to make the decision that is right for them."

Vicki Saporta, president of the National Abortion Federation also applauded the move, saying: "We are delighted that the FDA has approved a label change," as the new labeling could help protect abortion rights from political moves to restrict access to abortion.

Some states, including Texas, North Dakota and Ohio have laws requiring physicians to adhere to FDA's labeling for dosage and administration, while similar laws in Arizona, Arkansas and Oklahoma have been temporarily or permanently blocked by court order.

"These changes are a great step forward for women who need to access abortion, especially in North Dakota, Ohio and Texas … For women the changes result in the use of less medication, which lowers the risk of side effects and the cost," said Elizabeth Nash, senior state issues associate at the Guttmacher Institute, adding, "this was the right move by the FDA."

FDA, sNDA Approval Letter


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