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.
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?
Fuente: WSJ - 🏆 98. / 63 Leer más »
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Fuente: latimes - 🏆 11. / 82 Leer más »
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Fuente: CNN - 🏆 4. / 95 Leer más »
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 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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