Glenmark Pharma says USFDA has issued CRL for Ryaltris

Glenmark Pharma says USFDA has issued CRL for Ryaltris

Pharmaceuticals

Stock Analysis, IPO, Mutual Funds, Bonds & More

    The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing.

    PTI|

    Jun 22, 2019, 03.49 PM IST

    Agencies

    Glenmark Pharma says USFDA has issued CRL for Ryaltris
    The company said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.
    Glenmark Pharmaceuticals

    Saturday said the US Food and Drug Administration has issued a Complete Response Letter (

    CRL

    )regarding the

    new drug application

    for

    Ryaltris

    .

    The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing.

    "We would like to inform you that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray," Glenmark Pharmaceuticals said.

    "The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris. We feel confident that we should be able to resolve these issues within the next 6 to 9 months," it added.

    The company said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.

    Glenmark Pharma says USFDA has issued CRL for Ryaltris

    Also Read

    USFDA issues CRL for proposed biosimilar Pegfilgrastim: Biocon

    Biocon gets CRL from USFDA for anti-cancer drug

    Biocon rallies over 7% as USFDA issues CRL for proposed biosimilar

    SPARC advances over 6% on getting USFDA's CRL for Xelpros

    Commenting feature is disabled in your country/region.

    Copyright © 2019 Bennett, Coleman & Co. Ltd. All rights reserved. For reprint rights: Times Syndication Service

    Submit a Comment

    Captcha image