*Zena is an investigational drug product and is not FDA approved for OTC sale
Cadence OTC is here to bring the regular birth control pill over-the-counter. The commonly used birth control pill is a combination of two hormones, estrogen and progestin. Our goal is to make the combination pill available to people in the U.S. without the need for a prescription or insurance and at an affordable price.
- Are the most frequently prescribed pills (>90% of people who take the pill currently take a combined pill)
- Have been used by more than 300 million people worldwide
- Have been FDA approved for prescription use for more than 60 years
There are 2.8 million unintended pregnancies in the U.S. each year — almost half of all pregnancies.
The three biggest barriers to getting birth control pills are prescription requirements, cost, and limited availability.
The unintended pregnancy rate is significantly higher in the U.S. than in many other developed countries.
Our experts are working diligently with the FDA right now. The FDA approval process takes time. It’s intense. It’s careful. It’s rigorous. And we wouldn’t have it any other way.
Acquire rights to FDA-approved Rx products
Submit plan to FDA for switching to OTC
Establish product manufacturing
Collaborate with FDA on proposed OTC label & package development
Test proposed OTC labels & packaging with consumers
Finalize Zena go-to-market strategy and online consumer questionnaire
Leading physician groups and public health experts have evaluated the case for The Pill being available OTC and have publicly declared their support. Two public health nonprofit groups have advocated for policy to support the Pill being available OTC: Contraceptive Access Initiative and Free The Pill.
The U.S. has the highest infant and maternal mortality rates of any developed country. Increasing access to the birth control pill and Morning After Pill gives people across the country the options they want.