Final decision by the Office of Commissioner would provide more certainty than Covis’ proposal to voluntarily withdraw Makena ‘at some point in the future’ and assure that generic versions of the preterm birth prevention drug come off the market at the same time, the US FDA’s drugs center tells the Pink Sheet.

‘Ad hoc narrowing’ of the final voting question by hearing officer Celia Witten prevented adcomm members from voting on Covis’ proposal to restrict the preterm birth prevention drug's indication while further study was conducted, company says.

Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.

CBER’s Celia Witten is the latest senior executive to run an office within the center during a leadership transition, a move that can help achieve specific goals, but also create tension.