October 17 – 19, 2022
Day 1 :

Day 2:



Center for Drug Evaluation and Research

Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this Advisory Committee meeting via an online teleconference platform.


The Commissioner’s Office is holding a hearing under 21 CFR 314.530 on the Center of Drug Evaluation and Research’s proposal to withdraw expedited approval of Makena (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL)) . As part of the hearing process, the Obstetrical, Reproductive and Urological Drugs Advisory Committee (the Committee) will discuss whether a confirmatory trial has verified the clinical benefit of Makena and whether the available evidence demonstrates that Makena is effective for its approved indication, which is to reduce the risk of preterm birth in women with a single pregnancy who have a history of a single spontaneous preterm birth. The committee will also discuss whether the FDA should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.

The hearing will be held in a virtual format. Details will be provided in a future communication to the Federal Register. Members of the public, including ANDA holders, wishing to make a formal presentation at the hearing should register at the following link by 5:00 p.m. EDT on September 6, 2022: To complete your request for an opportunity to present at the hearing, you must also submit a comment to the docket for this hearing matter (DOCKET NO. FDA-2020-N-2029) by 11:59 p.m. EDT September 6. . 2022, and clearly indicate in the header and/or cover page that your comment is a “Request for Oral Presentation”.

A notice in the Federal Register about last-minute changes that impact a previously announced advisory committee meeting may not always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) for possible changes before coming to the meeting.

People attending FDA advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. The FDA welcomes public participation in its advisory committee meetings and will make every effort to accommodate people with disabilities. If you require accommodations due to a disability, please contact the Committee’s Designated Federal Officer (see Contact Information) at least 7 days prior to the meeting.

Answers to frequently asked questions, including information regarding special accommodations due to disability, can be found at: Common Questions and Answers About FDA Advisory Committee Meetings.

The FDA is committed to ensuring the smooth running of its advisory committee meetings. Please visit our website at Public Conduct During FDA Advisory Committee Meetings for procedures regarding public conduct during Advisory Committee meetings.

Notice of this meeting is given pursuant to the Federal Advisory Committee Act (5 USC app.2).