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FDA Considers Withdrawing Makena Approval
October 10, 2020AMAG Pharmaceuticals has received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection). -
AMAG's confirmatory study of Makena to reduce risk of preterm birth misses main goals
March 11, 2019AMAG Pharmaceuticals said Friday that a confirmatory study of Makena (hydroxyprogesterone caproate) in patients with a history of a prior spontaneous singleton preterm delivery failed to meet its co-primary endpoints. Shares in the company, which gained a
Pharma Sources Insight January 2025
