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.period of several months so that women taking the drug could complete their treatment.
The decision by FDA Commissioner Robert Califf and the agency’s chief scientist marks the first time the FDA has formally forced the removal of a drug that it initially approved based on promising early data. In all prior cases, drugmakers voluntarily pulled medications after the FDA made clear it intended to order removal.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes,” Califf said in a statement Thursday.
US_FDA will approve this dangerous drug for 12 years while safe and effective NurOwn for 100% fatal disease ALS is blocked by FDACBER. PALS DiedWaiting DyingWaiting MakesNoSense katiecouric USNewsHealth WSJhealth SenSusanCollins POTUS SenatorBraun lisamurkowski
Now do the covid vax
Classic FDA. Bought and paid for by Big Pharma since 1992.
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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
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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.
더 많은 것을 읽으십시오 »
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.
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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... I smell some up coming big big pharma litigation.
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