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  • FDA Issues Complete Response Letter for Ryaltris americanpharmaceuticalreview
    June 26, 2019
    India generic drug manufacturer, Glenmark, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.
  • FDA Issues Complete Response Letter for NDA for Dasotraline americanpharmaceuticalreview
    September 03, 2018
    Sunovion Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatme

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