FDA forces unproven premature birth drug Makena off market -
The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries.
The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy. It can cause side effects, including blood clots, depression and allergic reactions. Given those risks, FDA staffers previously concluded there was no upside to keeping the drug available, given its lack of confirmed benefit.
The FDA has been working to get the drug off the market since then, though Covis repeatedly appealed for more time to conduct further research.
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 »
Where exactly each dollar you spend on food goes: farmers get 14 cents and 4 cents pays for packagingA new report examines what each food dollar pays for, from food processing to packaging.
Baca lebih lajut »
FDA plans to allow a second updated COVID booster for vulnerable AmericansThe FDA plans to allow older and immunocompromised Americans to get a second updated coronavirus booster shot in the near future, an acknowledgment of the virus’s continuing risks to vulnerable people.
Baca lebih lajut »
Eyedrops maker couldn't ensure factory was sterile, FDA saysThe Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops
Baca lebih lajut »