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FDA knocks back Glenmark's allergic rhinitis therapy Ryaltris

Published on 25/06/19 at 10:24am

Stocks in Indian pharmaceutical firm Glenmark were sent plummeting to a six-year low after it was confirmed that the FDA had raised concerns over the company’s New Drug Application for Ryaltris (olopatadinehydrochloride and mometasonefuroate) in the treatment of seasonal allergic rhinitis.

The company’s shares fell 7% when it announced via a short press release that it had received a Complete Response Letter from the US regulator. The company’s release noted that the FDA’s concerns centred on “deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in the manufacturing facilities.”

Beyond this, further details on the nature of these concerns or deficiencies were not given. However, Glenmark made it known that they were not related to the clinical data submitted in support of the Rylatris application.  

 Despite the setback, the drugmaker said they would continue to push for regulatory approval of the drug in collaboration with the FDA. “We feel confident that we should be able to resolve these issues within the next six to nine months,” the company said.

Matt Fellows

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