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    • TABLET;ORAL - 40MG
    • TABLET;ORAL - 80MG
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    Sun Pharma issues recall of gout drug due to contamination
    Sun Pharma issues recall of gout drug due to contamination

    https://www.fiercepharma.com/manufacturing/sun-pharma-issues-recall-gout-drug-due-microbial-contamination

    Joseph Keenan FIERCE PHARMA
    11 Mar 2024
    Share Share
    Enforcement Report - Week of February 14, 2024
    Enforcement Report - Week of February 14, 2024

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-14-2024-75684.pdf

    FDA
    14 Feb 2024
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    Torrent Pharma's Generic Febuxostat Receives Approval in the U.S.
    Torrent Pharma's Generic Febuxostat Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211837

    FDA
    19 Dec 2023
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    Krka's febuxostat Receives Approval in Europe
    Krka's febuxostat Receives Approval in Europe

    https://www.ema.europa.eu/en/documents/overview/febuxostat-krka-epar-medicine-overview_en.pdf

    EMA
    15 Dec 2023
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    We are extremely happy to share the successful filling of Febuxostat USDMF with the USFDA
    We are extremely happy to share the successful filling of Febuxostat USDMF with the USFDA

    https://amilifesciences.com/media.php

    PRESS RELEASE
    18 Feb 2023
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    Zydus gets US FDA final nod for Febuxostat tablets for treating high uric acid
    Zydus gets US FDA final nod for Febuxostat tablets for treating high uric acid

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-gets-us-fda-final-nod-for-febuxostat-tablets-for-treating-high-uric-acid/articleshow/97006879.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

    ECONOMIC TIMES
    15 Jan 2023
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    Zydus' Generic Febuxostat Receives Approval in the U.S.
    Zydus' Generic Febuxostat Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205443

    FDA
    09 Jan 2023
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    Identrix's Generic Timolol Maleate Receives Approval in the U.S.
    Identrix's Generic Timolol Maleate Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212592

    FDA
    13 Dec 2021
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    Alkem Lab's Generic Febuxostat Receives Approval in the U.S.
    Alkem Lab's Generic Febuxostat Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212924

    FDA
    06 Dec 2021
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    Sunshine Lake Generic Febuxostat Receives Approval in US
    Sunshine Lake Generic Febuxostat Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213069

    FDA
    09 Jun 2020
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    MSN Labs subsidiary, Novadoz Pharma gets US FDA approval for generic Uloric
    MSN Labs subsidiary, Novadoz Pharma gets US FDA approval for generic Uloric

    http://www.pharmabiz.com/NewsDetails.aspx?aid=120269&sid=2

    PHARMABIZ
    01 Jan 2020
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    Novadoz Pharmaceuticals/MSN Labs granted FDA Approval of generic Febuxostat
    Novadoz Pharmaceuticals/MSN Labs granted FDA Approval of generic Febuxostat

    https://www.prnewswire.com/news-releases/novadoz-pharmaceuticalsmsn-labs-is-granted-fda-approval-of-generic-febuxostat-tablets-begins-immediate-shipping-300979945.html

    PR NEWSWIRE
    31 Dec 2019
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    Indoco Remedies gets US FDA approval for febuxostat tablets
    Indoco Remedies gets US FDA approval for febuxostat tablets

    http://www.pharmabiz.com/NewsDetails.aspx?aid=120267&sid=2

    PHARMABIZ
    31 Dec 2019
    Share Share
    MSN's Generic Febuxostat Receives Approval in US
    MSN's Generic Febuxostat Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210461

    FDA
    31 Dec 2019
    Share Share
    Indoco Remedies Generic Febuxostat Receives Approval in US
    Indoco Remedies Generic Febuxostat Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210292

    FDA
    31 Dec 2019
    Share Share
    Health Canada Issues Recall of Teijin Limited ULORIC ® (febuxostat)
    Health Canada Issues Recall of Teijin Limited ULORIC ® (febuxostat)

    https://www.pharmacompass.com/pdf/news/health-canada-issues-recall-of-teijin-limited-uloric-febuxostat-1573284888.pdf

    HEALTH CANADA
    05 Nov 2019
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    West-Ward Pharms Int`s Generic Febuxostat Receives Approval in US
    West-Ward Pharms Int`s Generic Febuxostat Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205414

    FDA
    17 Oct 2019
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    MYLAN PHARMS' generic FEBUXOSTAT Receives Approval in US
    MYLAN PHARMS' generic FEBUXOSTAT Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205385

    FDA
    01 Jul 2019
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    ALEMBIC PHARMS' generic FEBUXOSTAT Receives Approval in US
    ALEMBIC PHARMS' generic FEBUXOSTAT Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205421

    FDA
    01 Jul 2019
    Share Share
    Sun Pharm's generic FEBUXOSTAT Receives Approval in US
    Sun Pharm's generic FEBUXOSTAT Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205467

    FDA
    01 Jul 2019
    Share Share
    Takeda sets December deadline for U.S. employees' Boston move
    Takeda sets December deadline for U.S. employees' Boston move

    https://www.fiercepharma.com/pharma/goodbye-deerfield-takeda-sets-december-deadline-for-reassignment-1-000-u-s-employees

    K. Blankenship FIERCE PHARMA
    27 Jun 2019
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    MSN Laboratories' Generic Febuxostat Receives Tentative Approval In US
    MSN Laboratories' Generic Febuxostat Receives Tentative Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210461

    USA
    26 Jun 2019
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    Krka, d.d. Novo mesto's Febuxostat Krka ( Febuxostat) Receives Approval in Europe
    Krka, d.d. Novo mesto's Febuxostat Krka ( Febuxostat) Receives Approval in Europe

    https://www.pharmacompass.com/pdf/news/krka-dd-novo-mestos-febuxostat-krka-febuxostat-receives-approval-in-europe-1553940289.pdf

    EMA
    29 Mar 2019
    Share Share
    FDA restricts Takeda's gout drug Uloric on death-risk data
    FDA restricts Takeda's gout drug Uloric on death-risk data

    https://www.fiercepharma.com/pharma/takeda-s-uloric-suffers-fda-safety-setback-report-increased-death-risks

    Angus Liu FIERCE PHARMA
    23 Feb 2019
    Share Share
    FDA Adds Boxed Warning To Gout Drug Uloric
    FDA Adds Boxed Warning To Gout Drug Uloric

    https://www.rttnews.com/story.aspx?Id=2981067

    RTTNEWS
    21 Feb 2019
    Share Share
    Torrent Pharms' Generic Febuxostat Receives Tentative Approval in US
    Torrent Pharms' Generic Febuxostat Receives Tentative Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211837

    FDA
    05 Feb 2019
    Share Share
    EMA’s CHMP Recommends 6 New Meds, Releases Outcome of Sartan Investigation
    EMA’s CHMP Recommends 6 New Meds, Releases Outcome of Sartan Investigation

    https://www.raps.org/news-and-articles/news-articles/2019/2/emas-chmp-recommends-six-new-medicines-releases?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%201%20February

    Ana Mulero RAPS
    01 Feb 2019
    Share Share
    Zydus Pharms' Generic Febuxostat Receives Tentative Approval in US
    Zydus Pharms' Generic Febuxostat Receives Tentative Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205443

    FDA
    21 Dec 2018
    Share Share
    Uloric® (Febuxostat): Teijin Limited et al v. MSN Laboratories Private
    Uloric® (Febuxostat): Teijin Limited et al v. MSN Laboratories Private

    https://www.pharmacompass.com/pdf/news/uloric-febuxostat-teijin-limited-et-al-v-msn-laboratories-private-1529317923.pdf

    PATENT LITIGATION
    14 Jun 2018
    Share Share
    Newer gout drug poses risk to heart patients
    Newer gout drug poses risk to heart patients

    https://www.reuters.com/article/us-health-heart-gout-drug/newer-gout-drug-poses-risk-to-heart-patients-idUSKCN1GO26V

    Gene Emery REUTERS
    12 Mar 2018
    Share Share
    Mylan's Febuxostat Receives Approval In Europe
    Mylan's Febuxostat Receives Approval In Europe

    https://www.pharmacompass.com/pdf/news/mylans-febuxostat-receives-approval-in-europe-1508476981.pdf

    EMA
    20 Oct 2017
    Share Share
    Macleods Pharm’s Generic Febuxostat Receives Approval In US
    Macleods Pharm’s Generic Febuxostat Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207293

    FDA
    31 Jul 2017
    Share Share
    Design of experiment approach in development of febuxostat nanocrystal
    Design of experiment approach in development of febuxostat nanocrystal

    http://www.pharma-excipients.ch/2016/09/13/design-of-experiment-approach-in-development-of-febuxostat-nanocrystal-application-of-soluplus-as-stabilizer/

    PHARMA-EXCIPIENTS
    13 Sep 2016
    Share Share
    Alembic Pharma gets tentative nod from USFDA for Febuxostat
    Alembic Pharma gets tentative nod from USFDA for Febuxostat

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-gets-tentative-nod-from-usfda-for-febuxostat/articleshow/53057262.cms

    ECONOMIC TIMES
    05 Jul 2016
    Share Share
    Japan's MHLW slated to review Nippon Boehringer high blood pressure combo
    Japan's MHLW slated to review Nippon Boehringer high blood pressure combo

    http://www.fiercepharmaasia.com/story/japans-mhlw-slated-review-nippon-boehringer-high-blood-pressure-combo/2016-04-13

    EJ Lane FIERCE PHARMA ASIA
    13 Apr 2016
    Share Share
    TWi Biotechnology Inc. Reports Positive Interim Results from AC-201 CR
    TWi Biotechnology Inc. Reports Positive Interim Results from AC-201 CR

    http://www.prnewswire.com/news-releases/twi-biotechnology-inc-reports-positive-interim-results-from-ac-201-cr-phase-2-proof-of-concept-study-in-gout-patients-300197049.html

    PR NEWS WIRE
    24 Dec 2015
    Share Share
    New Indication for Teijin Pharma's Febuxostat in Europe
    New Indication for Teijin Pharma's Febuxostat in Europe

    http://www.pharmaasia.com/article/new-indication-for-teijin-pharma-febuxostat-in-europe/11805

    Denice Cabel PHARMA ASIA
    02 Jul 2015
    Share Share
    AZ's phase III gout data frustrates firm
    AZ's phase III gout data frustrates firm

    http://www.pmlive.com/pharma_news/azs_phase_iii_gout_data_frustrates_firm_758595

    Phil Taylor PM LIVE
    16 Jun 2015
    Share Share
    Higher dose of AZ' gout drug hits PhIII goals
    Higher dose of AZ' gout drug hits PhIII goals

    http://www.pharmatimes.com/Article/15-06-14/Higher_dose_of_AZ_gout_drug_hits_PhIII_goals.aspx?

    Selina Mckee PHARMA TIMES
    15 Jun 2015
    Share Share
    CymaBay Drug Not Better Than Current Care In Reducing Uric Acid
    CymaBay Drug Not Better Than Current Care In Reducing Uric Acid

    http://www.reuters.com/article/2015/02/24/us-cymabay-urgent-idUSKBN0LS11Y20150224

    Rosmi Shaji And Vidya L Nathan REUTERS
    25 Feb 2015
    Share Share
    Astrazeneca\'s $1.3B Gout Drug Comes Under EU Scrutiny
    Astrazeneca's $1.3B Gout Drug Comes Under EU Scrutiny

    http://www.fiercebiotech.com/story/astrazenecas-13b-gout-drug-comes-under-eu-scrutiny/2015-01-22

    Damian Garde FIERCE BIOTECH
    24 Jan 2015
    Share Share
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