FDA Approves FEMLYV, the First Dissolvable Birth Control Pill

For the 51% of women who suffer from dysphagia, the medical term for difficulty swallowing, Millicent Pharma’s FEMLYV should come as a relief: It’s the first orally disintegrating tablet approved for pregnancy prevention by the US Food and Drug Administration, the agency said in a July announcement.

FEMLYV (norethindrone acetate and ethinyl estradiol) 1 mg/0.02 mg is a combination pill packaged in the familiar calendar blister pack format used for most birth control pills (as shown below).

Image: FDA

Packaging uses a familiar calendar blister pack format

It comes in a carton of three pouches with each pouch containing a blister card of 28 orally disintegrating tablets (ODTs). ODTs typically require packaging with barrier properties that protect them from moisture and air, ensuring their stability and effectiveness. Packaging Digest reached out to Millicent to learn more about FEMLYV's packaging but was unable to reach anyone for comment.

Users take one green active pill daily for 24 days, followed by one white inert pill for four days. To further aid compliance, users pick a day label strip that starts with the first day of their period and place it on the tablet dispenser over the area that has the days of the week (starting with Sunday) printed on the plastic.

Related:How do you Package America’s First OTC Birth Control Pill?

FDA's approval of FEMLYV is one of two exciting firsts for the birth control pill over the past year: In 2023, FDA approved Opill, the first OTC birth control pill. Opill is now available on retail shelves and via online marketplaces, including Amazon.