Posted from: Thursday, September 19, 2019 - 09:36 AM - Present

Taclonex and Enstilar Granted Extended Approvals

August 1, 2019 – The U.S. FDA has granted extended approvals to Enstilar® (calcipotriene and betamethasone dipropionate) foam 0.005%/0.064% and Taclonex® (calcipotriene and betamethasone dipropionate) topical suspension, both manufactured by Leo Pharma.

Previously approved for adult patients, Enstilar and Taclonex are now indicated to provide topical treatment of plaque psoriasis of the body and scalp in patients 12 years of age and older.

Recommended dosing with Enstilar is no more than 60g every four days. Enstilar can be applied to affected areas once a day for a maximum of four weeks, and should be discontinued sooner if psoriasis control is achieved. For Taclonex, the recommended dosing is no more than 100g per week in adults and 60g per week in pediatric patients. The product should be applied to affected areas once a day until psoriasis is controlled, up to a maximum of eight weeks.

The active ingredients of both products have been FDA-approved since 2006.

Last Updated Friday, October 18, 2019 - 12:31 AM.