Ascend Therapeutics Draws FDA Untitled Letter Over Estrogel Claims

Regulatory NewsRegulatory News | 28 August 2018 |  By 

The US Food and Drug Administration (FDA) issued an untitled letter Tuesday to Ascend Therapeutics over “misleading claims and/or representations” regarding an Estrogel pamphlet.
“This sell sheet 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,” said FDA’s Office of Prescription Drug Promotion (OPDP).
The letter takes issue with claims on the company’s website regarding the efficacy of its FDA-approved prescription drug, which is indicated for treatment of menopausal changes.
One of the claims states that the “dose of estradiol in EstroGel has been proven to be the lowest effective dose for the treatment of symptomatic postmenopausal women,” said OPDP. But the cited research for this claim lacked comparisons to other FDA-approved estradiol formulations.
The letter calls on Ascend to “immediately cease violating the FD&C Act” and respond by the end of the month with explanations on whether it will comply with OPDP’s request and how.
The company also received an FDA untitled letter in 2015 over its claims relating to Estrogel.


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