Allergan: FDA Accepts NDA For Acne Drug Seysara

(RTTNews) - Allergan plc, (AGN) and Paratek Pharmaceuticals Inc. (PRTK) announced that the U.S. Food and Drug Administration has accepted New Drug Application to review Seysara for moderate to severe acne vulgaris in patients 9 years of age and older.

Allergan expects the Prescription Drug User Fee Act action date to occur in the second half of 2018. Allergan has U.S. rights to the development and commercialization of Seysara. Paratek retains all ex-U.S. rights.

Seysara (sarecycline) is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting.

Allergan owns the U.S. rights to sarecycline, developed by Paratek Pharmaceuticals, when Actavis acquired Allergan in 2015.