Mayne Pharma Faces FDA Action Over ‘Misleading’ Drug Safety Claims Ahead of $430M Buyout
The U.S. FDA has accused Mayne Pharma of presenting misleading safety claims about its oral contraceptive Nextstellis, especially in comparison to other estrogen-containing contraceptives145.
The FDA's concerns center on a presentation slide deck, which the agency says minimized Nextstellis’s risks and incorrectly suggested estetrol (its active estrogen) is safer or fundamentally different from other estrogens like ethinyl estradiol134.
Some claims implied that Nextstellis offers a 'low impact' and 'minimal effect on the liver,' suggesting superior safety without sufficient evidence, which the FDA said has "not been demonstrated"13.
The FDA flagged suggestions that Nextstellis may have a lower risk for breast and liver issues, when in fact it is contraindicated in patients with a current or history of breast cancer, as well as other significant health risks4.
Mayne Pharma was sent an untitled letter and a cease and desist order by the FDA's Office of Prescription Drug Promotion on April 28, 202545.
This regulatory action comes as Mayne Pharma is in the final stages of a $430 million acquisition by Cosette Pharmaceuticals, expected to close in Q2 202545.
Nextstellis was approved in 2021 and carries a boxed warning for increased cardiovascular risks, particularly from cigarette smoking4.
Sources:
1. https://www.fiercepharma.com/marketing/mayne-430m-deal-weeks-away-hit-misleading-drug-safety-claims-fda
3. https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/maynes-nextstellis-promo-wrong-to-suggest-better-safety-than-other-contraceptives-fda-says-OKZMAO5YLFDX7OWF5MUP3PZRVI/
4. https://www.tabletscapsules.com/3639-News/619315-FDA-Flags-Mayne-for-Misleading-Claims-About-Birth-Control-Pill-Safety/