
(AGENPARL) – SILVER SPRING gio 06 aprile 2023 FDA CDER proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use
Fonte/Source: http://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information