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Treatment for Allergic Rhinitis

FDA Issues Complete Response Letter for Ryaltris NDA

June 25, 2019 -- Glenmark Pharma on Saturday said the US Food and Drug Administration (USFDA) 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.

"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," the company said in a regulatory filing.

Glenmark Pharma said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.

Source: Glenmark Pharma

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