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.
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“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.”