Setback For Glenmark As FDA Hands Out CRL For Ryaltris

India's Glenmark gets US Complete Response Letter for Ryaltris but emphasizes the FDA hasn’t faulted the clinical data for the product, and that the action won’t impact recent alliances for the rhinitis asset.  

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Glenmark Positive Despite Ryaltris CRL • Source: Shutterstock

Shares of Glenmark Pharmaceuticals Ltd. slumped on Indian bourses after the firm said that its investigational rhinitis therapy Ryaltris (olopatadine HCl/mometasone furoate nasal spray) had received a Complete Response Letter from the US FDA, stretching potential launch timelines into 2020.

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