PROTOPIC TACROLIMUS OINTMENT 0.1

FDA Warning Letter, Fujisawa Healthcare, Inc. (Protopic (tacrolimus) Ointment 0.03%, 0.1%) This letter objects to Fujisawa Healthcare, Inc. (Fujisawa) dissemination of violative promotional materials for Protopic (tacrolimus) Ointment 0.03%, 0.1%. As part of its monitoring program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of a direct-to-consumer (DTC) television (TV) broadcast advertisement and DTC print advertisements for Protopic that are false or misleading in violation of the federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations. The DTC television broadcast advertisement ( Awakenings, 60 second spot, PCA88103) and DTC print advertisements (Adult - PT064, Caregiver - PT065), submitted under cover of form FDA 2253, are violative for the reasons described below. These claims suggest that Protopic Ointment is indicated as first line therapy to treat all types of atopic dermatitis. However, the PI states, PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated for short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies. Therefore, the TV advertisement is misleading because it suggests that Protopic Ointment is approved for use in a broader patient population and a broader range of conditions than what has been demonstrated by substantial evidence.