The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing
Glenmark Pharmaceuticals said the US Food and Drug Administration has issued a Complete Response Letter (CRL)regarding the new drug application for Ryaltris.
The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing.
“We would like to inform you that the US Food and Drug Administration (US FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray,” Glenmark Pharmaceuticals said.
“The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris. We feel confident that we should be able to resolve these issues within the next 6 to 9 months,” it added.
The company said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.