The Food and Drug Administration on Thursday revoked the approval of Makena, the latest — and probably last — chapter of a long-running saga involving the only drug cleared to reduce the risk of preterm birth.
Covis, which is owned by private equity firm Apollo Global Management, argued that yanking the drug would hurt Black women, and that the larger trial was flawed because it did not have a significant proportion of Black patients. It wanted to conduct another trial to prove its point. Some Black health groups also supported keeping the drug on the market.
Last fall, 15 outside advisers to the FDA voted unanimously that the drug did not help mothers or babies and all but one said it should be removed from the market. Covis then offered its “wind-down” plan. But the FDA drug center wanted an immediate withdrawal, so the issue went to the FDA commissioner and the agency’s chief scientist, Namandjé Bumpus.
Before Makena was approved, pharmacists sometimes made their own versions by compounding drugs that included the active ingredient, hydroxyprogesterone caproate.
Indonesia Berita Terbaru, Indonesia Berita utama
Similar News:Anda juga dapat membaca berita serupa dengan ini yang kami kumpulkan dari sumber berita lain.
FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market
Baca lebih lajut »
FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market.
Baca lebih lajut »
FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women.
Baca lebih lajut »
FDA pulls pre-term birth drug Makena and its generics from market after 12 yearsThe U.S. Food and Drug Administration said Thursday it has reached a final decision to fully withdraw approval of pre-term birth drug Makena and its...
Baca lebih lajut »
Ted Lasso Recap: Keeping it 2011Ted finally realizes that he may indeed be a mess.
Baca lebih lajut »
How 2011’s The Thing Fits Into The Original Movie’s TimelineDespite having the same title, 2011's The Thing is not a remake of John Carpenter's The Thing. It fits perfectly into the 1982 film's timeline.
Baca lebih lajut »