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    • TABLET, EXTENDED RELEASE;ORAL - 1.5MG
    • TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • TABLET, EXTENDED RELEASE;ORAL - 3MG
    • TABLET, EXTENDED RELEASE;ORAL - 6MG
    • TABLET, EXTENDED RELEASE;ORAL - 9MG
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    Ascent Pharma' Generic Paliperidone Receives Approval in the U.S.
    Ascent Pharma' Generic Paliperidone Receives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216174

    FDA
    23 Aug 2023
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    J&J successfully defends against Viatris' Invega copycat
    J&J successfully defends against Viatris' Invega copycat

    https://www.fiercepharma.com/pharma/jj-beats-back-viatris-generic-challenge-3-month-schizophrenia-med-invega-trinza

    Fraiser Kansteiner FIERCE PHARMA
    19 May 2023
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    Enforcement Report - Week of March 16, 2022
    Enforcement Report - Week of March 16, 2022

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-16-2022-1647498663.pdf

    FDA
    17 Mar 2022
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    Health Canada Recalls Marcan Pharmaceutical's MAR-Paliperidone Extended Release tablets
    Health Canada Recalls Marcan Pharmaceutical's MAR-Paliperidone Extended Release tablets

    https://www.pharmacompass.com/pdf/news/health-canada-recalls-marcan-pharmaceuticals-mar-paliperidone-extended-release-tablets-1637731856.pdf

    Health Canada
    16 Nov 2021
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    ANI Announces Launch of Paliperidone Extended-Release Tablets
    ANI Announces Launch of Paliperidone Extended-Release Tablets

    https://www.prnewswire.com/news-releases/ani-announces-launch-of-paliperidone-extended-release-tablets-300986321.html

    PR NEWSWIRE
    14 Jan 2020
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    Inventia Healthcare's Generic Paliperidone Receives Approval in US
    Inventia Healthcare's Generic Paliperidone Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204452

    FDA
    12 Jun 2019
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    Alkermes says long-acting drugs help schizophrenics stay on medication longer
    Alkermes says long-acting drugs help schizophrenics stay on medication longer

    https://www.reuters.com/article/us-alkermes-study/alkermes-says-long-acting-drugs-could-help-schizophrenics-stay-on-medication-longer-idUSKCN1RL19O

    Saumya Joseph REUTERS
    10 Apr 2019
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    Janssen's Trevicta Receives Approval in Europe
    Janssen's Trevicta Receives Approval in Europe

    https://www.ema.europa.eu/documents/procedural-steps-after/trevicta-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf

    EMA
    20 Oct 2018
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    Janssen-Cilag Internatl NV's Invega (paliperidone) Receives Approval in Europe
    Janssen-Cilag Internatl NV's Invega (paliperidone) Receives Approval in Europe

    https://www.ema.europa.eu/documents/overview/invega-epar-summary-public_en.pdf

    EMA
    01 Oct 2018
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    Sun Pharma’s Generic Paliperidone Receives Approval In US
    Sun Pharma’s Generic Paliperidone Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205618

    FDA
    11 Apr 2018
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    Invega Sustenna® (Paliperidone):Janssen Pharmaceuticals V. Teva Pharmas Usa
    Invega Sustenna® (Paliperidone):Janssen Pharmaceuticals V. Teva Pharmas Usa

    https://insight.rpxcorp.com/litigation_documents/12773120

    PATENT LITIGATION
    17 Jan 2018
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    FDA Confirms Paragraph IV Patent Challenge of Invega Sustenna (Paliperidone Palmitate) Extended-release Injectable Suspension
    FDA Confirms Paragraph IV Patent Challenge of Invega Sustenna (Paliperidone Palmitate) Extended-release Injectable Suspension

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-invega-sustennapaliperidone-palmitate-extended-release-injectable-suspension-1512710971.pdf

    FDA
    08 Dec 2017
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    Enforcement Report - Week of July 19, 2017
    Enforcement Report - Week of July 19, 2017

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-19-2017-1500439616.pdf

    FDA
    19 Jul 2017
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    Teva Pharmaceuticals, USA Extends Voluntary Nationwide Recall
    Teva Pharmaceuticals, USA Extends Voluntary Nationwide Recall

    https://www.pharmacompass.com/pdf/news/teva-pharmaceuticals-usa-extends-voluntary-nationwide-recall-1497595124.pdf

    FDA
    16 Jun 2017
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    Lawyers Investigate Invega Gynecomastia Lawsuits Against Janssen
    Lawyers Investigate Invega Gynecomastia Lawsuits Against Janssen

    http://www.newsinferno.com/lawyers-investigate-invega-gynecomastia-lawsuits-against-janssen/

    Lillian Chiu NEWSINFERNO
    18 Jan 2017
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    US FDA Enforcement Report- 18/May/2016
    US FDA Enforcement Report- 18/May/2016

    https://www.pharmacompass.com/pdf/news/us-fda-enforcement-report-18may2016-1463569543.pdf

    FDA
    17 May 2016
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    FDA warns of potentially fatal skin reactions to Lilly's Zyprexa
    FDA warns of potentially fatal skin reactions to Lilly's Zyprexa

    http://www.fiercepharma.com/pharma/fda-warns-potentially-fatal-skin-reactions-linked-to-lilly-s-zyprexa

    Emily Wasserman FIERCE PHARMA
    12 May 2016
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    CHMP adopts positive opinion of Trevicta, maintenance treatment of schizophrenia
    CHMP adopts positive opinion of Trevicta, maintenance treatment of schizophrenia

    http://www.europeanpharmaceuticalreview.com/40223/news/industry-news/chmp-trevicta-schizophrenia/

    Victoria White EUROPEAN PHARMACEUTICAL REVIEW
    05 Apr 2016
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    Fake smiles star in Otsuka and Lundbeck's DTC push for Rexulti in depression
    Fake smiles star in Otsuka and Lundbeck's DTC push for Rexulti in depression

    http://www.fiercepharmamarketing.com/story/fake-smiles-star-otsuka-and-lundbecks-dtc-push-rexulti-depression/2016-03-09

    Beth Snyder Bulik FIERCE PHARMA MARKETING
    10 Mar 2016
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    Otsuka stares down rival with FDA approval for Alkermes' long-acting Abilify
    Otsuka stares down rival with FDA approval for Alkermes' long-acting Abilify

    http://www.fiercepharma.com/story/otsuka-stares-down-another-rival-fda-approval-alkermes-long-acting-abilify/2015-10-06

    Emily Wasserman FIERCE PHARMA
    07 Oct 2015
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    Mylan releases generic version of Invega in the U.S.
    Mylan releases generic version of Invega in the U.S.

    http://www.news-medical.net/news/20150928/Mylan-releases-generic-version-of-Invega-in-the-US.aspx?utm_source=twitterfeed&utm_medium=twitter&utm_campaign=DTN+Pharma+News:

    NEWS MEDICAL
    29 Sep 2015
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    Allergan Launches Generic Version of INVEGA® (paliperidone)
    Allergan Launches Generic Version of INVEGA® (paliperidone)

    http://www.prnewswire.com/news-releases/allergan-launches-generic-version-of-invega-paliperidone-300148943.html

    PR NEWS WIRE
    26 Sep 2015
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    Janssen's Invega Trinza (3- Month Paliperidone Palmitate) Approved in US For Schizophrenia
    Janssen's Invega Trinza (3- Month Paliperidone Palmitate) Approved in US For Schizophrenia

    http://www.janssenpharmaceuticalsinc.com/assets/Invega%20Trinza%20Approval%20Press%20Release%20Clean%205%2018%2015%20-%20FINAL.pdf

    Press Release JANSSEN
    20 May 2015
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    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
    Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002310.jsp&mid=WC0b01ac058004d5c1

    EMA
    24 Apr 2015
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    Report Card: FDA Earns a Solid
    Report Card: FDA Earns a Solid

    http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/01/report-card-fda-gets-a-solid-b-on-timely-responding-to-section-505w-discontinuation-citizen-petition.html

    Kurt R. Karst FDA LAW BLOG
    25 Jan 2015
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    Janssen`s Generic Paliperidone Janssen (Paliperidone 25 mg, 50 mg, 75 mg, 100 mg and 150 mg) Approved in Europe for Schizophrenia
    Janssen`s Generic Paliperidone Janssen (Paliperidone 25 mg, 50 mg, 75 mg, 100 mg and 150 mg) Approved in Europe for Schizophrenia

    http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/004066/WC500180643.pdf

    EMA
    21 Jan 2015
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