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FDA Approves Rhofade for Adult Rosacea

Allergan news release; 2017 Jan 19

The US Food and Drug Administration (FDA) has approved RHOFADE (oxymetazoline hydrochloride) cream 1% for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. RHOFADE is manufactured by Allergan plc, headquartered in Dublin, Ireland, and will be available for commercial supply in the US starting May 2017.

Indications: RHOFADE cream 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

Dosage and administration: Each gram of RHOFADE cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base. Prime pump bottle before initial use and discard product from first 3 pumps. Apply a pea-sized amount once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin), avoiding the eyes and lips. Wash hands after application.

Adverse reactions: The most common adverse reactions for RHOFADE were: application site dermatitis (2%), worsening inflammatory lesions of rosacea (1%), application site pruritus (1%), application site erythema (1%), and application site pain (1%).

Citation:

Allergan announces FDA approval Of RHOFADE™ (oxymetazoline Hydrochloride) cream, 1% for the topical treatment of persistent facial erythema associated with rosacea in adults. Dublin, Ireland: Allergan news release January 19, 2017. http://www.allergan.com/NEWS/News/Thomson-Reuters/Allergan-Announces-FDA-Approval-Of-RHOFADE-Oxymet. Accessed January 23, 2017.