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WASHINGTON – The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex, formerly known as RU-486, to 70 days of gestation from 49 days.
Mifeprex was approved by the FDA in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent certain gastric ulcers.
The agency also approved reductions in the recommended Mifeprex dosing. Instead of taking three 200 mg tablets on day one patients will take one 200 mg tablet. In future, patients will be required to take 800 mcg of misoprostol 24-48 hours after taking Mifeprex. Previously they took 400 mcg on day three.
“This new regimen has been recognized by the American Medical Association and the American College of Obstetricians and Gynecologists as “superior” to the regimen on the previously FDA-approved label,” Planned Parenthood said in a statement.
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The new label is expected to make it easier, less expensive and more convenient for patients to take the pill.
Under the old label, patients were asked to return to their doctor 14 days after taking Mifeprex for an examination. The new label requires that they return between seven and 14 days for an “assessment.”