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FDA pushes to remove pregnancy drug, company pushes back

KIFI

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — The maker of a drug intended to reduce premature births is making a last-ditch effort to keep its medication on the market, even as health regulators insist that it doesn’t work. The Food and Drug Administration is hosting a three-day meeting that started Monday to review the scientific data on Makena. Currently it is the only U.S. drug approved to reduce dangerously early births. The FDA granted accelerated approval to the injected drug in 2011 based on promising early results. But for the last two years the FDA has been pushing for its withdrawal, citing follow-up data showing the drug didn’t benefit mothers or their babies.

Article Topic Follows: AP National Business

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