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    Nitisinone

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    NEWS #PharmaBuzz

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    Cycle Pharma Harliku Tablets FDA-Approved for Alkaptonuria
    Cycle Pharma Harliku Tablets FDA-Approved for Alkaptonuria

    20 Jun 2025

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20250611798305/en/Cycle-Pharmaceuticals-HARLIKU-nitisinone-Tablets-Receive-First-FDA-Approval-as-Treatment-for-Alkaptonuria-AKU

    BUSINESSWIRE
    20 Jun 2025
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    Eton Pharmaceuticals Reports First Quarter 2024 Financial Results
    Eton Pharmaceuticals Reports First Quarter 2024 Financial Results

    09 May 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/05/09/2879121/0/en/Eton-Pharmaceuticals-Reports-First-Quarter-2024-Financial-Results.html

    GLOBENEWSWIRE
    09 May 2024
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    Eton Announces Commercial Availability of Nitisinone Capsules
    Eton Announces Commercial Availability of Nitisinone Capsules

    02 Feb 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com//news-release/2024/02/02/2822744/0/en/Eton-Pharmaceuticals-Announces-Commercial-Availability-of-Ultra-Rare-Disease-Product-Nitisinone-Capsules.html

    GLOBENEWSWIRE
    02 Feb 2024
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    Torrent's Generic Nitisinone Receives Approval in the U.S.
    Torrent's Generic Nitisinone Receives Approval in the U.S.

    09 Jan 2023

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215908

    FDA
    09 Jan 2023
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    Sobi’s Orfadin Receives Positive Opinion From CHMP For Treatment Of AKU
    Sobi’s Orfadin Receives Positive Opinion From CHMP For Treatment Of AKU

    20 Sep 2020

    // PHARMABIZ

    http://www.pharmabiz.com/NewsDetails.aspx?aid=131249&sid=2

    PHARMABIZ
    20 Sep 2020
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    Orfadin® (nitisinone) receives positive opinion from CHMP for treatment of AKU
    Orfadin® (nitisinone) receives positive opinion from CHMP for treatment of AKU

    18 Sep 2020

    // BIOSPACE

    https://www.biospace.com/article/releases/orfadin-nitisinone-receives-positive-opinion-from-chmp-for-treatment-of-aku/

    BIOSPACE
    18 Sep 2020
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