FDA issues Complete Response Letter for Ryaltris

The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for Ryaltris (olopatadine hydrochloride [665mcg] and mometasone furoate [25mcg]), nasal spray, a treatment for seasonal allergic rhinitis (SAR), India’s Glenmark Pharmaceuticals (BSE: 532296) revealed in a Bombay Stock Exchange filing.

The CRL cites deficiencies in the Drug Master File (DMF) relating 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 NDA for Ryaltris. “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,” said Glenmark.

Shares of Glenmark Pharmaceuticals hit a 52-week low of 467 rupees, down 7% on the BSE in the early morning trade on Monday after the revelation. The stock was trading at its lowest level since April 4, 2013.