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.
Glenmark said that the CRL cited deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in the manufacturing facilities, but underscored that the agency had not flagged any deficiencies with the clinical data supporting the New Drug Application for Ryaltris
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