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    Lupin's Generic Tolvaptan Receives Approval in the U.S.
    Lupin's Generic Tolvaptan Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216063

    FDA
    05 Oct 2023
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    Hetero's Generic Tolvaptan Receives Approval in the U.S.
    Hetero's Generic Tolvaptan Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205646

    FDA
    06 Sep 2022
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    Apotex's Generic Tolvaptan Receives Approval in the U.S.
    Apotex's Generic Tolvaptan Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207605

    FDA
    06 Sep 2022
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    Alkem's Generic Tolvaptan Receives Approval in the U.S.
    Alkem's Generic Tolvaptan Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211891

    FDA
    06 Sep 2022
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    Palladio Biosciences Announces Presentation of Data from a Study of Lixivaptan
    Palladio Biosciences Announces Presentation of Data from a Study of Lixivaptan

    https://www.businesswire.com/news/home/20201020005214/en

    BUSINESSWIRE
    20 Oct 2020
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    Alkem Lab Generic Tolvaptan Receives Approval in US
    Alkem Lab Generic Tolvaptan Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211891

    FDA
    23 May 2020
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    Apotex's Generic Tolvaptan Receives Approval in US
    Apotex's Generic Tolvaptan Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207605

    FDA
    23 May 2020
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    Alkem Lab's Generic Tolvaptan Receives Tentative Approval in US
    Alkem Lab's Generic Tolvaptan Receives Tentative Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211891

    FDA
    31 Jan 2020
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    Daiichi-Sankyo, Bayer, Otsuka & Others Called Out for UK Advertisement Breaches
    Daiichi-Sankyo, Bayer, Otsuka & Others Called Out for UK Advertisement Breaches

    https://www.raps.org/news-and-articles/news-articles/2019/8/daiichi-sankyo-bayer-otsuka-and-others-called-ou

    RAPS
    12 Aug 2019
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    Otsuka Pharmaceutical's Samsca (tolvaptan) Receives Approval in Europe
    Otsuka Pharmaceutical's Samsca (tolvaptan) Receives Approval in Europe

    https://www.ema.europa.eu/documents/product-information/samsca-epar-product-information_en.pdf

    EMA
    12 Oct 2018
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    EC approves extension of indication for Otsuka’s tolvaptan for CKD
    EC approves extension of indication for Otsuka’s tolvaptan for CKD

    https://www.businesswire.com/news/home/20180802005360/en

    BUSINESSWIRE
    02 Aug 2018
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    Samsca® (tolvaptan): Otsuka Pharmaceutical Co., Ltd., v. Alkem Laboratories Ltd.,
    Samsca® (tolvaptan): Otsuka Pharmaceutical Co., Ltd., v. Alkem Laboratories Ltd.,

    https://www.pharmacompass.com/pdf/news/samsca-tolvaptan-otsuka-pharmaceutical-co-ltd-v-alkem-laboratories-ltd-1530593115.pdf

    PATENT LITIGATION
    29 Jun 2018
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    FDA Confirms Paragraph IV Patent Challenge of Samsca (Tolvaptan) Tablets
    FDA Confirms Paragraph IV Patent Challenge of Samsca (Tolvaptan) Tablets

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-samsca-tolvaptan-tablets-1527227706.pdf

    FDA
    23 May 2018
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    Otsuka Announces Ph3 Results for Tolvaptan in Patients with Autosomal Disease
    Otsuka Announces Ph3 Results for Tolvaptan in Patients with Autosomal Disease

    http://www.businesswire.com/news/home/20171104005040/en/Otsuka-Announces-Phase-3-Results-Tolvaptan-Patients/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

    BUSINESSWIRE
    06 Nov 2017
    Share Share
    Otsuka to Host Web Briefing on Tolvaptan Ph3 Trial Results in Polycystic KD
    Otsuka to Host Web Briefing on Tolvaptan Ph3 Trial Results in Polycystic KD

    http://www.businesswire.com/news/home/20171027005212/en/Otsuka-Host-Web-Briefing-Tolvaptan-Phase-3/?feedref=JjAwJuNHiystnCoBq_hl-WFAllVCLJFCqzlmaJ8DKHU4plfPZtlGYRDUHCSmgbii6XkLWuQZD-HgGRnjQvCyg3iCfEFIaJW7-otp9V1XQiK2eHTJy3ZqOEt7kKgLu20J

    BUSINESSWIRE
    27 Oct 2017
    Share Share
    Otsuka Announces Results of Phase 3 Data on Tolvaptan
    Otsuka Announces Results of Phase 3 Data on Tolvaptan

    http://www.businesswire.com/news/home/20170522005405/en/Otsuka-Announces-Results-Phase-3-Data-Tolvaptan/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

    BUSINESSWIRE
    22 May 2017
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    Six new therapies approved for NHS Scotland
    Six new therapies approved for NHS Scotland

    http://www.pharmatimes.com/Article/16-01-12/Six_new_therapies_approved_for_NHS_Scotland.aspx

    Selina McKee PHARMATIMES
    12 Jan 2016
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    Otsuka's Jinarc (Tolvaptan) Approved in US For Polycystic Kidney Disease
    Otsuka's Jinarc (Tolvaptan) Approved in US For Polycystic Kidney Disease

    http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002788/WC500187924.pdf

    Press Release EMA
    13 Jun 2015
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    Otsuka's Jinarc (Tolvaptan) Approved in Canada for ADPKD
    Otsuka's Jinarc (Tolvaptan) Approved in Canada for ADPKD

    http://www.otsuka.co.jp/en/company/release/2015/0227_03.html

    Press Release OTSUKA
    28 Feb 2015
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    Jinarc Recommended for Approval in Rare Kidney Disease
    Jinarc Recommended for Approval in Rare Kidney Disease

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/02/news_detail_002280.jsp&mid=WC0b01ac058004d5c1

    EMA
    27 Feb 2015
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