FDA Policy/General

False, Misleading EstroGel Sell Sheet: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says a professional sell sheet for Ascend Therapeutics’ EstroGel 0.06% (estradiol gel) makes false or misleading claims and/or representations about the drug’s efficacy. An 8/16 Notice of Violation says the 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.”

The notice says that EstroGel is indicated for treating moderate to severe vasomotor symptoms due to menopause and treating moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. The product is associated with Boxed Warnings for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia. The labeling also contains Contraindications, Warnings, and Precautions.

OPDP says the sell sheet’s claims are false or misleading because they suggest that EstroGel provides the lowest effective dose of estrogen for the treatment of moderate to severe vasomotor symptoms due to menopause and treating moderate to severe symptoms of vulvar and vaginal atrophy due to menopause compared to other estrogen therapies, including transdermal estrogen therapies, when this is not the case. Although the sell sheet cites two studies to support its claims, neither of them provides support, OPDP says.

Ascend was told to immediately stop making violative claims for EstroGel and to submit a list of all violative promotional materials with a plan for discontinuing their use.

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