Posted by Michael Wonder on 23 Jun 2019
FDA issues complete response letter for Ryaltris (olopatadine hydrochloride and mometasone furoate)
22 June 2019 - We would like to inform you that the U.S. FDA has issued a complete response letter regarding the new drug application for Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray.
The letter cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in the manufacturing facilities.
