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    Colistimethate Sodium

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    Essential Pharma acquires European rights to Colobreathe from Teva
    Essential Pharma acquires European rights to Colobreathe from Teva

    08 Jan 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com//news-release/2024/01/08/2805070/0/en/Essential-Pharma-acquires-European-rights-to-Colobreathe-colistimethate-sodium-from-Teva.html

    GLOBENEWSWIRE
    08 Jan 2024
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    Zambon Receives U.S. FDA Breakthrough Therapy Designation for CMS I-neb®
    Zambon Receives U.S. FDA Breakthrough Therapy Designation for CMS I-neb®

    21 Apr 2022

    // PRESS RELEASE

    https://www.zambon.com/en/media/press/2022-04-21-zambon-receives-us-fda-breakthrough-therapy-designation-cms-i-nebr-patients

    PRESS RELEASE
    21 Apr 2022
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    EU drug regulators review use of last-resort antibiotic in farming
    EU drug regulators review use of last-resort antibiotic in farming

    11 Jan 2016

    // Kate Kelland REUTERS

    http://www.reuters.com/article/us-health-antibiotics-europe-idUSKCN0UP1QK20160111

    Kate Kelland REUTERS
    11 Jan 2016
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    Xellia's Generic Colistimethate Sodium (Eq 150Mg Base/Vial) Approved in US For Bacterial Infections
    Xellia's Generic Colistimethate Sodium (Eq 150Mg Base/Vial) Approved in US For Bacterial Infections

    03 Jun 2015

    // FDA

    http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205356Orig1s000ltr.pdf

    FDA
    03 Jun 2015
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    Heritage Pharmaceuticals, Inc., Ongoing Class II recall of Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31 because of Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
    Heritage Pharmaceuticals, Inc., Ongoing Class II recall of Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31 because of Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

    25 Mar 2015

    // FDA

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0415-2015&w=03252015&lang=eng

    FDA
    25 Mar 2015
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    Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial Due to a Lack of Sterility Assurance
    Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial Due to a Lack of Sterility Assurance

    24 Feb 2015

    // Press Release USFDA

    http://www.fda.gov/Safety/Recalls/ucm435560.htm

    Press Release USFDA
    24 Feb 2015
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