Glenmark Pharmaceuticals has informed that the US Food and Drug Administration (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. 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. The Company feels confident that it 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.
The above information is a part of company’s filings submitted to BSE.
