FDA pulls pre-term birth drug Makena and its generics from market after 12 years

The 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 generics, a full 12 years after it hit the market. The drug was approved using the agency’s accelerate approval pathway in 2011 as a way to reduce the risk of pre-term birth in women pregnant with one baby who had a history of spontaneous pre-term birth.

The drug was approved using the agency’s accelerate approval pathway in 2011 as a way to reduce the risk of pre-term birth in women pregnant with one baby who had a history of spontaneous pre-term birth.

I smell some up coming big big pharma litigation.

Portugal Últimas Notícias, Portugal Manchetes

Similar News:Você também pode ler notícias semelhantes a esta que coletamos de outras fontes de notícias.

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
Fonte: WOKVNews - 🏆 247. / 63 Consulte Mais informação »

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.
Fonte: ksatnews - 🏆 442. / 53 Consulte Mais informação »

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.
Fonte: WashTimes - 🏆 235. / 63 Consulte Mais informação »