The drug, Makena, is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. It's the only drug with FDA approval to reduce the risk of premature birth.
Indeed, the timing of the drug's removal remains uncertain. Covis, based in Switzerland, said in its release that FDA regulators rejected its proposal to wind down the drug's use over several months. But the FDA made clear it would continue its internal process to force the drug's removal on its own terms, according to the company. FDA Commissioner Robert Califf is expected to soon decide on the drug's fate, in consultation with the agency's top scientist.Covis made its proposal to the FDA following an October public meeting at which outside advisers overwhelmingly concluded that Makena hasn't been shown to work and should have its approval revoked.
The company added that it"remains ready to work cooperatively with the agency," to remove the drug, despite disagreement on the timeframe.
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Go get your clot shot though clowns
dbchirpy unproven means it very well may not work.
Not a doctor but I strongly question the health well being of all birth control users. It's very unnatural and disruptive to the body. I feel like it really impacts so many women physically, mentally, psychologically.
mRNA next
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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?
Source: WSJ - 🏆 98. / 63 Read more »
Drug to prevent preterm birth pulled from market, years after it was shown ineffectiveCovis Pharma said it told the Food and Drug Administration that it would voluntarily withdraw the medicine called Makena, which a study in 2019 showed did not work to extend pregnancies. Last year, melodypetersen detailed how Covis and the companies that previously owned the rights to Makena profited by taking a cheap, decades-old medicine with questionable effectiveness and safety and securing FDA authorization for its use. MelodyPetersen But I thought big pharma loved and cared about us.
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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?
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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
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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 !
Source: AP - 🏆 728. / 51 Read more »
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.
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