Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
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%).
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.
This Week's Must Reads
Vermilion vs Cutaneous Location in cSCC of the Lip, JAMA Dermatology; ePub 2018 May 2; Wang, et al
Autoimmune Disease Risk in Patients with CLE, JAMA Dermatology; ePub 2018 May 2; Kunzler, et al
Identifying Shiny White Streaks in Melanoma, J Am Acad Dermatol; 2018 May; Verzi, et al
Digital Dermoscopic Image Analyzer Evaluated, J Am Acad Dermatol; 2018 May; del Rosario, et al
Red/Processed Meat Inversely Linked with Melanoma, J Am Acad Dermatol; ePub 2018 Apr 23; Yen, Li, et al
Must Reads in FDA Actions
FDA Approves Ilumya for Plaque Psoriasis, Sun Pharmaceutical Industries Ltd. news release; 2018 Mar
FDA Approves Label Update for Cosentyx, Novartis news release; 2018 Feb 8
FDA Approves Xepi Topical Antibiotic for Impetigo, Medimetriks Pharmaceuticals, Inc. news release; 2017 Dec 14
FDA Approves New Pfizer Biosimilar Ixifi, Pfizer news release; 2017 Dec 13
FDA Clears CoolSculpting for Double Chin Treatment, Allergan plc news release; 2017 Dec 12
