Amag Pharma down on petition to remove Makena from U.S. market

AMAG Pharmaceuticals (AMAG -3.5%) is under modest pressure on below-average volume in apparent reaction to a petition filed with the FDA by the consumer advocacy group Public Citizen requesting the removal of Makena (hydroxyprogesterone caproate injection) from the U.S. market. The agency first approved the drug, under accelerated review status, in February 2011 to reduce the risk of preterm birth in at-risk pregnant women.

Public Citizen says that the drug’s effectiveness is unproven, citing the results from a 2018 Phase 3 study, PROLONG, that failed to show a statistically significant treatment benefit compared to placebo.

https://seekingalpha.com/news/3504556-amag-pharma-4-percent-petition-remove-makena-u-s-market