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    • POWDER;INHALATION - 28MG
    • SOLUTION/DROPS;OPHTHALMIC - 0.3%
    • OINTMENT;OPHTHALMIC - 0.3%
    • SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%
    • OINTMENT;OPHTHALMIC - 0.1%;0.3%
    • SOLUTION;INHALATION - 300MG/5ML
    • SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%
    Full View ScreenFull Screen View
    Enforcement Report - Week of August 23, 2023
    Enforcement Report - Week of August 23, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-23-2023-6184.pdf

    FDA
    23 Aug 2023
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    Alembic, Aurobindo Pharma issue separate US drug recalls
    Alembic, Aurobindo Pharma issue separate US drug recalls

    https://www.fiercepharma.com/manufacturing/alembic-aurobindo-pharma-issue-recalls-citing-quality-and-production-issues

    Joseph Keenan FIERCE PHARMA
    21 Aug 2023
    Share Share
    Enforcement Report - Week of June 7, 2023
    Enforcement Report - Week of June 7, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-7-2023-80553.pdf

    FDA
    07 Jun 2023
    Share Share
    Enforcement Report - Week of February 1, 2023
    Enforcement Report - Week of February 1, 2023

    https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=print.getPrintData&ts=11202310416

    FDA
    01 Feb 2023
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    Enforcement Report - Week of January 25, 2023
    Enforcement Report - Week of January 25, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-25-2023-68767.pdf

    FDA
    25 Jan 2023
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    ImprimisRx Launches Fortisite Compounded Antibiotic Formulation
    ImprimisRx Launches Fortisite Compounded Antibiotic Formulation

    https://www.businesswire.com/news/home/20220929005297/en

    BUSINESSWIRE
    29 Sep 2022
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    Mankind's Generic Tobramycin Receives Approval in the U.S.
    Mankind's Generic Tobramycin Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216725

    FDA
    22 Sep 2022
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    Enforcement Report - Week of June 15, 2022
    Enforcement Report - Week of June 15, 2022

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-15-2022-1655268880.pdf

    FDA
    14 Jun 2022
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    Padagis Announces the FDA Approval and Launch of an AB Rated Generic Version of Tobradex® Ophthalmic Suspension
    Padagis Announces the FDA Approval and Launch of an AB Rated Generic Version of Tobradex® Ophthalmic Suspension

    https://padagis.com/padagis-annouces-the-fda-approval-and-launch-of-an-ab-rated-generic-version-of-tobradex-ophthalmic-suspension/

    PRESS RELEASE
    21 Mar 2022
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    Padagis' Generic Tobramycin and Dexamethasone Receives Approval in the U.S.
    Padagis' Generic Tobramycin and Dexamethasone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212715

    FDA
    11 Feb 2022
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    Health Canada Issues Recall of Sterimax's Tobramycin Injection USP 40mg/ml
    Health Canada Issues Recall of Sterimax's Tobramycin Injection USP 40mg/ml

    https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75897r-eng.php

    HEALTH CANADA
    06 Jun 2021
    Share Share
    7-day levofloxacin/dexamethasone eye drops as effective as standard
    7-day levofloxacin/dexamethasone eye drops as effective as standard

    https://www.news-medical.net/news/20200713/7-day-levofloxacindexamethasone-eye-drops-as-effective-as-standard-treatment-after-cataract-surgery.aspx

    Levofloxacin NEWS-MEDICAL
    13 Jul 2020
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    Sun Pharma`s Generic Deferasirox Receives Approval in US
    Sun Pharma`s Generic Deferasirox Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207136

    FDA
    27 Dec 2019
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    Eyevance Pharmaceuticals Acquires TOBRADEX® ST and NATACYN®
    Eyevance Pharmaceuticals Acquires TOBRADEX® ST and NATACYN®

    https://www.prnewswire.com/news-releases/eyevance-pharmaceuticals-acquires-tobradex-st-and-natacyn-300939668.html

    PR NEWSWIRE
    17 Oct 2019
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    Mylan gains marketing authorization for TOBI Podhaler and TOBI Solution
    Mylan gains marketing authorization for TOBI Podhaler and TOBI Solution

    https://www.thepharmaletter.com/article/mylan-gains-marketing-authorization-for-tobi-podhaler-and-tobi-solution

    THE PHARMALETTER
    22 Jul 2019
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    TEVA PHARMS USA Generic Tobramycin Receives Approval In US
    TEVA PHARMS USA Generic Tobramycin Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210915

    FDA
    26 Jun 2019
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    Seven medicines leap closer to EU approval
    Seven medicines leap closer to EU approval

    http://www.pharmatimes.com/news/seven_medicines_leap_closer_to_eu_approval_1272896

    Selina McK PHARMA TIMES
    18 Dec 2018
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    Meeting highlights from the CHMP 10-13 December 2018
    Meeting highlights from the CHMP 10-13 December 2018

    https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-december-2018

    14 Dec 2018
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    Dr Reddys Labs Intl’s Generic Tobramycin Receives Approval in the US
    Dr Reddys Labs Intl’s Generic Tobramycin Receives Approval in the US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207080

    FDA
    12 Jul 2018
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    Lupin launches generic antibiotic inhalation solution in US
    Lupin launches generic antibiotic inhalation solution in US

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-launches-generic-antibiotic-inhalation-solution-in-us/articleshow/64574026.cms

    ECONOMIC TIMES
    13 Jun 2018
    Share Share
    Enforcement Report - Week of May 16, 2018
    Enforcement Report - Week of May 16, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-16-2018-1526446624.pdf

    FDA
    16 May 2018
    Share Share
    FDA Confirms Paragraph IV Patent Challenge of Bethkis (Tobramycin) Inhalation Solution
    FDA Confirms Paragraph IV Patent Challenge of Bethkis (Tobramycin) Inhalation Solution

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-bethkis-tobramycin-inhalation-solution-1509424916.pdf

    FDA
    30 Oct 2017
    Share Share
    Mylan Pharm’s Generic Tobramycin Receives Approval In US
    Mylan Pharm’s Generic Tobramycin Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209554

    FDA
    17 Oct 2017
    Share Share
    Somerset Theraps Generic Tobramycin Receives Approval In US
    Somerset Theraps Generic Tobramycin Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207444

    FDA
    29 Jun 2017
    Share Share
    Lupin Atlantis Generic Tobramycin Receives Approval In US
    Lupin Atlantis Generic Tobramycin Receives Approval In US

    http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208964

    FDA
    22 Mar 2017
    Share Share
    Sun Pharma gets European Medicines Agency nod for Tobramycin
    Sun Pharma gets European Medicines Agency nod for Tobramycin

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sun-pharma-gets-european-medicines-agency-nod-for-tobramycin/articleshow/57189274.cms

    ECONOMIC TIMES
    16 Feb 2017
    Share Share
    Warp Drive Bio Hands Over Antibiotics Program to Sanofi
    Warp Drive Bio Hands Over Antibiotics Program to Sanofi

    http://www.biospace.com/News/warp-drive-bio-hands-over-antibiotics-program-to/440459/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

    Mark Terry BIOSPACE
    30 Nov 2016
    Share Share
    Sanofi Partnership Passes First Test With Delivery of Antibiotic Compounds
    Sanofi Partnership Passes First Test With Delivery of Antibiotic Compounds

    http://www.wsj.com/articles/sanofi-receives-antibiotic-compounds-from-partnership-1480431064

    JONATHAN D. ROCKOFF WALL STREET JOURNAL
    29 Nov 2016
    Share Share
    Claris gets USFDA nod for anti-bacterial infections injection
    Claris gets USFDA nod for anti-bacterial infections injection

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/claris-gets-usfda-nod-for-anti-bacterial-infections-injection/articleshow/53079235.cms

    ECONOMIC TIMES
    07 Jul 2016
    Share Share
    The relevance of solid state properties of aminoglycoside antibiotics
    The relevance of solid state properties of aminoglycoside antibiotics

    http://www.pharma-excipients.ch/2016/03/18/the-relevance-of-solid-state-properties-of-aminoglycoside-antibiotics-to-dry-powder-dispersion-in-a-dpi/

    PHARMA-EXCIPIENTS
    17 Mar 2016
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    FDA Drug Shortages: Tobramycin Injection
    FDA Drug Shortages: Tobramycin Injection

    http://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Tobramycin+Injection&source=govdelivery&st=c&tab=tabs-4&utm_medium=email&utm_source=govdelivery

    FDA
    25 Mar 2015
    Share Share
    Pari Pharma's Vantobra (Tobramycin) Approved in Europe For RTI and Cystic Fibrosis
    Pari Pharma's Vantobra (Tobramycin) Approved in Europe For RTI and Cystic Fibrosis

    http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002633/WC500184462.pdf

    Press Release EMA
    20 Mar 2015
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    Walgreens Infusion Services, Ongoing Class II recall of Tobramycin various strengths in normal saline bags because of Lack of sterility assurance.
    Walgreens Infusion Services, Ongoing Class II recall of Tobramycin various strengths in normal saline bags because of Lack of sterility assurance.

    http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0354-2015&w=01282015&lang=eng

    FDA
    28 Jan 2015
    Share Share
    Pharmacy Creations, Ongoing Class I recall of Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. because of Non-Sterility: Failing sterility results were obtained from the recalling firm\'s contract testing facility indicating that the products may not be sterile.
    Pharmacy Creations, Ongoing Class I recall of Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution, 1 mL Dropper in a 3 mL bottle, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756. because of Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

    Http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0308-2015&w=12312014&lang=eng
    31 Dec 2014
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