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Zena is a candidate to be the first combination birth control pill available to women throughout the US (and beyond) without a prescription.

Already proven safe and effective, we’re working to make it an affordable and accessible option for all women.

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If You Know About The Pill, You Know Zena

Zena is a high-quality oral contraceptive (aka “The Pill”) with a long history of safety and efficacy when taken as directed. Zena has the most commonly prescribed low-dose oral contraceptive estrogen and progestin formulation prescribed by doctors and health professionals for more than two decades.

For Zena to be approved for sale without a prescription, the Food and Drug Administration (FDA) requires extensive testing of over-the-counter (OTC) labeling before approval. Our experts are working diligently with the FDA towards approval for Zena.

Steps to Approval

For the safety of all, the FDA’s standard approval process is careful and rigorous, and we wouldn’t have it any other way.

 
Rx product approved by FDA
Long Rx safety record
Submit plan to FDA for switching to OTC
Collaborate with FDA on OTC label & package development
Test new OTC labels & packaging with consumers
Conduct an 1800+ participant actual use trial (AUT)
FDA and Advisory Committee review OTC data
FDA decides if OTC status is granted
Available at retailers without a prescription
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Why Bring The Pill Over the Counter?
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It's Safe

In its nearly 60-year history, The Pill has been used safely by more than 300 million women.

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It's Effective

Taken correctly, oral contraceptives like Zena are 99% effective in preventing pregnancy.

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It's Time

As early as 2012, and again in 2014, the American College of Obstetricians and Gynecologists endorsed over-the-counter access for The Pill.  The American Academy of Family Physicians, the American College of Clinical Pharmacists, and the American Public Health Association soon followed.

Why Bring The Pill Over the Counter?
The Fascinating History of the Birth Control Pill

It’s been called one of the greatest scientific and social breakthroughs in human history. And for generations of women (and men!) that’s no exaggeration.

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