In a recent letter, the FDA requested that Takeda Pharmaceutical Co stop disseminating violative promotional materials for its prescription sleep aid, Rozerem.

The letter states, “The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed a Substance Abuse Patient Profile Sell Sheet (RAM-01071) (Sell Sheet) for Rozerem™ (ramelteon) Tablets (Rozerem) submitted by Takeda Pharmaceuticals North America, Inc. (Takeda) under cover of Form FDA-2253. The Sell Sheet is false or misleading because it makes unsubstantiated superiority presentations, omits and minimizes the risks associated with the use of Rozerem, omits material facts, and makes a misleading claim about Rozerem. The Sell Sheet thus misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act…”

The letter asked Takeda to submit a written response on whether the company intends to comply with the request to stop disseminating the materials in question and explain a plan for discontinuing distribution.