FDA Resurrects Vanished Birth Control Shot for Generic Copycats
Published Date: 12/12/2025
Notice
Summary
The FDA has decided that LUNELLE, a birth control shot, wasn’t taken off the market because it was unsafe or didn’t work. This means companies can now apply to make generic versions, which could make the shot more affordable and easier to get. Women who use or want this birth control might see more options soon, with no extra safety worries.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Generic Approval Allowed for LUNELLE
FDA determined that LUNELLE (estradiol cypionate 5 mg/0.5 mL and medroxyprogesterone acetate 25 mg/0.5 mL) was not withdrawn from sale for reasons of safety or effectiveness. This decision (published December 12, 2025) allows companies to submit abbreviated new drug applications (ANDAs) referring to LUNELLE, and FDA may approve those ANDAs if they meet all other legal and regulatory requirements, so you may see generic versions become available.
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