India generic drug manufacturer, Glenmark, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.
The CRL cites deficiencies in the Drug Master File (DMF) pertaining to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities.
“The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris,” according to a statement from Glenmark. “We feel confident that we should be able to resolve these issues within the next 6 to 9 months. Glenmark Pharmaceuticals will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.”