The US Food and Drug Administration hearing on a proposal to withdraw accelerated approval of Covis Pharma’s preterm birth prevention drug Makena (hydroxyprogesterone caproate) will likely take place in September or October and will be conducted virtually.
Makena Accelerated Approval Hearing Will Be Virtual, Likely In September Or October
Presiding officer Celia Witten denies Covis’ request for an in-person hearing, saying it is unclear at this time how COVID would affect a proceeding in the fall. Hearing agenda spans two-and-a-half days and is modeled, in part, on the Avastin hearing, but with twice the time for public comment.
