, though Covis has repeatedly appealed for more time to conduct additional research. The injectable drug has become a symbol for the challenges the FDA faces to withdraw a medication when the manufacturer won't do so voluntarily.
But the FDA made clear it would continue its process to force the drug’s removal on its own terms, according to the company. In a separate filing Wednesday, the agency's drug regulators recommended making the withdrawal “immediately effective.” The agency noted there's no indication of “harm from discontinuing Makena, such as signs or symptoms of withdrawal.”
Such hearings are extraordinarily rare and occur only after a drugmaker rejects initial FDA requests to pull its drug. About 10% of U.S. births come too early, before 37 weeks, raising the risk of serious health problems and even death in infants. The problem occurs at higher rates among Black women. Despite those results, reproductive specialists — including members of the American College of Obstetricians and Gynecologists — have argued for keeping the decade-old drug available while more research is done.
Berita ini telah kami rangkum agar Anda dapat membacanya dengan cepat. Jika Anda tertarik dengan beritanya, Anda dapat membaca teks lengkapnya di sini. Baca lebih lajut:
Indonesia Berita Terbaru, Indonesia Berita utama
Similar News:Anda juga dapat membaca berita serupa dengan ini yang kami kumpulkan dari sumber berita lain.
Maker of preterm birth drug Makena to withdraw it from market | CNNThe maker of the drug Makena, which was approved more than a decade ago to reduce the risk of preterm birth, said Tuesday that it is moving to withdraw the medication from the market after a US Food and Administration panel said it is not effective. Now if they would have only done that with the Covid vaccines. Think of the lives they would have saved. The vaccine has also proven not to work against c19 but your not pulling that. Wonder why?
Sumber: CNN - 🏆 4. / 95 Baca lebih lajut »
Maker of unproven birth drug Makena to pull from US marketThe maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the United States
Sumber: WOKVNews - 🏆 247. / 63 Baca lebih lajut »
Maker of unproven birth drug Makena to pull from US marketWASHINGTON (AP) — The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the U.S., after regulators signaled plans to follow through on a long-delayed effort to force it from the market . Cuz their abortion thirsty _FDAwriter This drug absolutely helped me carry my daughter to term , my two older sons where both born at 34 and 35 weeks respectively… my daughter was born at 37 weeks 5 days !
Sumber: AP - 🏆 728. / 51 Baca lebih lajut »
Maker of unproven birth drug Makena to pull from US marketThe injectable drug has become a symbol of the challenges the FDA faces to withdraw a medication when the manufacturer won’t do so voluntarily.
Sumber: AKNewsNow - 🏆 460. / 53 Baca lebih lajut »
Drug to Prevent Preterm Births to Be Pulled From MarketThe maker of Makena said it will stop selling the drug to prevent preterm births after a study couldn’t confirm the medicine worked Wtf are these things let out before we know this. Jesus f----- Christ Good, do aducanumab next. How did it get approved in the first place?
Sumber: WSJ - 🏆 98. / 63 Baca lebih lajut »