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.

Stada has celebrated “growing faster than the markets in which it operates” after delivering a 2022 performance that saw the firm’s earnings lifted in particular by increases in its consumer healthcare and specialty segments.