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Ascend’s EstroGel Promotion Misrepresents Efficacy Compared To Other Products, US FDA Says

 
• By Sue Sutter

Professional sell sheet falsely suggests estradiol gel contains lowest effective dose of estrogen compared to other estrogen products, OPDP says in fourth “untitled” letter of 2018.

Bad Apple
A bad apple?

A professional detailing aid misrepresents the efficacy of Ascend Therapeutics US LLC’s EstroGel relative to other estrogen products approved at lower doses, the US FDA’s Office of Prescription Drug Promotion (OPDP) said in a recent “untitled” letter.

The professional sell sheet for EstroGel 0.06% (estradiol gel) for topical use “is concerning because it falsely suggests that EstroGel contains the lowest effective dose of estrogen compared to other estrogen products when, in fact, there are other FDA-approved products that are available at doses lower than EstroGel,” the agency said in an Aug. 16

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Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

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• By Sue Sutter

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More from Compliance

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

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