FDA Updates Label to Lower Dosage, Extend Usage for Mifeprex

The FDA has approved a supplemental application for abortion drug Mifeprex, updating the label to lower the dosage and extend the usage period to 70 days gestation from 49.

In the application, Danco Laboratories submitted new data on the clinical practices, safety and efficacy of the drug, administered with misoprostol.

First approved in the U.S. in 2000, Mifeprex was previously prescribed at a dosage of 600 mg for the first treatment.