Covis Pharma Group, announced it has submitted a response to the Presiding Officer’s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the Center for Drug Evaluation and Research’s proposal to withdrawal approval for Makena®, the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.
March 7, 2023
· 2 min read