Glenmark Pharmaceuticals has suffered a major blow to its US respiratory plans after the Food and Drug Administration issued a complete response letter just as the Indian firm hoped to secure approval for its Ryaltris (olopatadine hydrochloride/mometasone furoate) nasal spray. The regulatory setback, which will push any approval into 2020 at the earliest, could also hamper the Indian firm’s attempts to recruit a commercial partner for the seasonal allergic rhinitis treatment.
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