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    Annora's Generic Mexiletine Hydrochloride Receives Approval in the U.S.
    Annora's Generic Mexiletine Hydrochloride Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216463

    FDA
    09 Nov 2022
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    Zenara's Generic Ketorolac Tromethamine Receives Approval in the U.S.
    Zenara's Generic Ketorolac Tromethamine Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215315

    FDA
    26 Aug 2022
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    UK recall of Clinigen’s Mexiletine hydrochloride hard capsules
    UK recall of Clinigen’s Mexiletine hydrochloride hard capsules

    https://www.europeanpharmaceuticalreview.com/news/173469/uk-recall-of-clinigens-mexiletine-hydrochloride-hard-capsules/

    EUROPEAN PHARMACEUTICAL REVIEW
    05 Aug 2022
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    Medis to commercialise Lupin’s orphan drug NaMuscla to treat myotonia in adults
    Medis to commercialise Lupin’s orphan drug NaMuscla to treat myotonia in adults

    http://www.pharmabiz.com/NewsDetails.aspx?aid=145760&sid=2

    PHARMABIZ
    10 Feb 2022
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    Senores launches Mexiletine HCl Capsules with top generic pharma companies
    Senores launches Mexiletine HCl Capsules with top generic pharma companies

    https://www.prnewswire.com/news-releases/senores-pharmaceuticals-inc-announces-the-launch-of-mexiletine-hydrochloride-capsules-usp-150-mg-200-mg-and-250-mg-with-one-of-the-top-generic-pharmaceutical-companies-in-the-us-market-301469562.html

    PRNEWSWIRE
    27 Jan 2022
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    Havix's Generic Mexiletine Hydrochloride Receives Approval in the US
    Havix's Generic Mexiletine Hydrochloride Receives Approval in the US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214089

    FDA
    01 Oct 2021
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    Scottish Medicines Consortium approves Lupin's NaMuscla® (mexiletine)
    Scottish Medicines Consortium approves Lupin's NaMuscla® (mexiletine)

    https://www.globenewswire.com/news-release/2020/12/08/2141074/0/en/Scottish-Medicines-Consortium-approves-Lupin-s-NaMuscla-mexiletine-to-treat-symptomatic-myotonia-in-adults-with-non-dystrophic-myotonic-disorders-NDM.html

    GLOBENEWSWIRE
    08 Dec 2020
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    Crossmedika SA`s Generic Mexiletine Hydrochloride Receives Approval in US
    Crossmedika SA`s Generic Mexiletine Hydrochloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213500

    FDA
    30 Jul 2020
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    Lannett Launches Mexiletine HCl Capsules
    Lannett Launches Mexiletine HCl Capsules

    https://www.prnewswire.com/news-releases/lannett-launches-mexiletine-hcl-capsules-301098574.html

    PRNEWSWIRE
    23 Jul 2020
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    ANI Pharmaceuticals Announces Launch of Mexiletine Hydrochloride Capsules
    ANI Pharmaceuticals Announces Launch of Mexiletine Hydrochloride Capsules

    https://www.prnewswire.com/news-releases/ani-pharmaceuticals-announces-launch-of-mexiletine-hydrochloride-capsules-301085595.html

    PRNEWSWIRE
    30 Jun 2020
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    Lupin’s mexiletine receives US FDA orphan drug to treat myotonic disorders
    Lupin’s mexiletine receives US FDA orphan drug to treat myotonic disorders

    http://pharmabiz.com/NewsDetails.aspx?aid=126677&sid=2

    PHARMABIZ
    07 Jun 2020
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    Lupin's Namuscla (mexiletine hydrochloride) Receives Approval in Europe
    Lupin's Namuscla (mexiletine hydrochloride) Receives Approval in Europe

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

    FDA
    04 Feb 2019
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    Lupin gets European Commission nod for myotonia treatment drug
    Lupin gets European Commission nod for myotonia treatment drug

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-gets-european-commission-nod-for-myotonia-treatment-drug/articleshow/67434286.cms

    ECONOMIC TIMES
    08 Jan 2019
    Share Share
    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)
    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)

    https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-october-2018

    EMA
    23 Oct 2018
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    EMA Recommends the First treatment for rare inherited muscle disorders
    EMA Recommends the First treatment for rare inherited muscle disorders

    https://www.ema.europa.eu/documents/press-release/first-treatment-rare-inherited-muscle-contraction-disorders_en.pdf

    EMA
    20 Oct 2018
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    Lupin Neurosciences Announces Positive CHMP Opinion for NaMuscla
    Lupin Neurosciences Announces Positive CHMP Opinion for NaMuscla

    https://markets.businessinsider.com/news/stocks/lupin-neurosciences-announces-positive-chmp-opinion-for-namuscla-for-the-treatment-of-myotonia-in-non-dystrophic-myotonic-disorders-1027633591

    BUSINESS INSIDER
    19 Oct 2018
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    IDT Australia release on FDA nod for 23 generics begs the question: Where's the beef?
    IDT Australia release on FDA nod for 23 generics begs the question: Where's the beef?

    http://www.fiercepharmaasia.com/story/idt-australia-release-fda-nod-23-generics-begs-question-wheres-beef/2015-04-14

    EJ Lane FIERCE PHARMA ASIA
    14 Apr 2015
    Share Share
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