The US FDA has scheduled a three-day meeting of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee (ORUDAC) from Monday to Wednesday, October 17- October 19, 2022. During the meeting, the Office of the Commissioner will overhear on the Center of Drug Evaluation and Research's proposal to withdraw accelerated approval of Makena (hydroxyprogesterone caproate injection, (250 mg/mL). As part of the hearing process, the Obstetrics, Reproductive and Urologic Drugs Advisory Committee will discuss whether a confirmatory trial verified the clinical benefit of Makena and whether available evidence demonstrates that Makena is effective for its approved indication, which is to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The Committee will also discuss whether FDA should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.