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.
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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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