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    • CREAM;TOPICAL - 0.005%
    • SOLUTION;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    • OINTMENT;TOPICAL - 0.064%;0.005%
    • SUSPENSION;TOPICAL - 0.064%;0.005%
    • AEROSOL, FOAM;TOPICAL - 0.005%
    Full View ScreenFull Screen View
    Enforcement Report - Week of June 7, 2023
    Enforcement Report - Week of June 7, 2023

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-7-2023-80553.pdf

    FDA
    07 Jun 2023
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    Glenmark gets USFDA nod for generic drug with 180-day exclusivity
    Glenmark gets USFDA nod for generic drug with 180-day exclusivity

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-gets-usfda-nod-for-generic-drug-with-180-day-exclusivity/articleshow/98934035.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

    ECONOMIC TIMES
    23 Mar 2023
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    EPI Health, a Novan Company, and MC2 Therapeutics Present WYNZORA®
    EPI Health, a Novan Company, and MC2 Therapeutics Present WYNZORA®

    https://www.globenewswire.com/news-release/2022/09/15/2516825/0/en/EPI-Health-a-Novan-Company-and-MC2-Therapeutics-Present-WYNZORA-calcipotriene-and-betamethasone-dipropionate-Cream-0-005-0-064-Subgroup-Data-Analysis-at-Skin-of-Color-Update-2022-C.html

    GLOBENEWSWIRE
    15 Sep 2022
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    Enforcement Report - Week of July 6, 2022
    Enforcement Report - Week of July 6, 2022

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-6-2022-1657105109.pdf

    FDA
    06 Jul 2022
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    Glenmark receives ANDA approval for topical treatment of plaque psoriasis
    Glenmark receives ANDA approval for topical treatment of plaque psoriasis

    https://health.economictimes.indiatimes.com/news/pharma/glenmark-receives-anda-approval-for-topical-treatment-of-plaque-psoriasis-in-adults/91434978

    ET HEALTH
    09 May 2022
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    EPI Health and MC2 Therapeutics Announce Wynzora(R) Cream (calcipotriene)
    EPI Health and MC2 Therapeutics Announce Wynzora(R) Cream (calcipotriene)

    https://finance.yahoo.com/news/epi-health-mc2-therapeutics-announce-130000824.html

    YAHOO
    09 Nov 2021
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    LEO Pharma announces U.S. FDA approval for Enstilar®
    LEO Pharma announces U.S. FDA approval for Enstilar®

    https://leo-pharma.com/media-center/news/leo-pharma-announces-us-fda-approval-for-enstilar-foam

    PRESS RELEASE
    23 Oct 2020
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    PerrigoUk Finco's Generic Betamethasone Dipropionate Receives Approval In US
    PerrigoUk Finco's Generic Betamethasone Dipropionate Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212367

    FDA
    15 Sep 2020
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    Taro's Generic BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE Receives Approval In US
    Taro's Generic BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213269

    FDA
    13 Sep 2020
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    FDA Confirms Paragraph IV Patent Challenge of Enstilar 207589 (Calcipotriene and Betamethasone Dipropionate) Topical Foam 0.005%/0.064%
    FDA Confirms Paragraph IV Patent Challenge of Enstilar 207589 (Calcipotriene and Betamethasone Dipropionate) Topical Foam 0.005%/0.064%

    https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-enstilar-207589-calcipotriene-and-betamethasone-dipropionate-topical-foam00050064-1597494793.pdf

    FDA
    12 Aug 2020
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    MC2 Therapeutics Announces FDA Approval of Wynzora® Cream
    MC2 Therapeutics Announces FDA Approval of Wynzora® Cream

    https://www.b3cnewswire.com/202007222098/mc2-therapeutics-announces-u-s-food-and-drug-administration-approval-of-wynzora-cream-calcipotriene-and-betamethasone-dipropionate-w-w-0-005-0-064-for-adults-with-plaque-psoriasis.html

    B3CNEWSWIRE
    21 Jul 2020
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    Lipidor, Cadila to conduct Ph III study of anti-psoriasis candidate
    Lipidor, Cadila to conduct Ph III study of anti-psoriasis candidate

    https://www.biospectrumasia.com/news/39/16250/lipidor-cadila-to-conduct-ph-iii-study-of-anti-psoriasis-candidate.html

    BIOSPECTRUMASIA
    07 Jul 2020
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    LEO Pharma Presents Results From Study of Twice-Weekly Enstilar®
    LEO Pharma Presents Results From Study of Twice-Weekly Enstilar®

    https://www.businesswire.com/news/home/20200612005254/en/LEO-Pharma-Presents-Results-Study-Twice-Weekly-Enstilar%C2%AE

    BUSINESSWIRE
    12 Jun 2020
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    Tolmar`s Generic Betamethasone Dipropionate;Calcipotriene Receives Approval in US
    Tolmar`s Generic Betamethasone Dipropionate;Calcipotriene Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210765

    FDA
    15 May 2020
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    Bicycle Therapeutics to Updated Data from PhI/IIa Trial Evaluating Lead BT1718
    Bicycle Therapeutics to Updated Data from PhI/IIa Trial Evaluating Lead BT1718

    https://www.businesswire.com/news/home/20190924005192/en/Bicycle-Therapeutics-Present-Updated-Data-Phase-IIIa/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

    BUSINESSWIRE
    24 Sep 2019
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    LEO Pharma Announces USFDA Expanded Regulatory Approvals for Enstilar®
    LEO Pharma Announces USFDA Expanded Regulatory Approvals for Enstilar®

    https://www.businesswire.com/news/home/20190731005636/en/LEO-Pharma-Announces-U.S.-Food-Drug-Administration/?feedref=JjAwJuNHiystnCoBq_hl-WFAllVCLJFCqzlmaJ8DKHU4plfPZtlGYRDUHCSmgbii6XkLWuQZD-HgGRnjQvCyg3iCfEFIaJW7-otp9V1XQiK2eHTJy3ZqOEt7kKgLu20J

    BUSINESSWIRE
    31 Jul 2019
    Share Share
    FDA approves SORILUX(R) for Adolescent Plaque Psoriasis
    FDA approves SORILUX(R) for Adolescent Plaque Psoriasis

    https://www.biospectrumasia.com/news/33/13521/fda-approves-soriluxr-for-adolescent-plaque-psoriasis.html

    BIOSPECTRUMASIA
    23 May 2019
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    Enforcement Report - Week of February 28, 2018
    Enforcement Report - Week of February 28, 2018

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-28-2018-1519803579.pdf

    FDA
    28 Feb 2018
    Share Share
    FDA approves Lupin’s generic Dovonex Scalp Solution
    FDA approves Lupin’s generic Dovonex Scalp Solution

    http://www.drugstorenews.com/article/fda-approves-lupins-generic-dovonex-scalp-solution

    DRUG STORE NEWS
    04 Jan 2018
    Share Share
    Novel Labs Generic Calcipotriene Receives Approval In US
    Novel Labs Generic Calcipotriene Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207163

    FDA
    29 Dec 2017
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    Enforcement Report - Week of March 15, 2017
    Enforcement Report - Week of March 15, 2017

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-15-2017-1489584258.pdf

    FDA
    15 Mar 2017
    Share Share
    Enforcement Report - Week of February 22, 2017
    Enforcement Report - Week of February 22, 2017

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-22-2017-1487758756.pdf

    FDA
    22 Feb 2017
    Share Share
    SMC green light for LEO’s Enstilar
    SMC green light for LEO’s Enstilar

    http://www.pharmatimes.com/news/smc_green_light_for_leos_enstilar_1132237

    Selina McKee PHARMATIMES
    16 Sep 2016
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    LEO Pharma Receives Scientific Approval of Enstilar® for the Treatment of Psoriasis in EU
    LEO Pharma Receives Scientific Approval of Enstilar® for the Treatment of Psoriasis in EU

    http://www.prnewswire.com/news-releases/leo-pharma-receives-scientific-approval-of-enstilar-for-the-treatment-of-psoriasis-in-eu-572901011.html

    PR NEWSWIRE
    21 Mar 2016
    Share Share
    Glenmark's Generic Calcipotriene (0.005% Topical) Approved in US For Psoriasis
    Glenmark's Generic Calcipotriene (0.005% Topical) Approved in US For Psoriasis

    http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205772Orig1s000ltr.pdf

    Press Release FDA
    12 Jun 2015
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    Glenmark's Generic Calcipotriene (0.005%) Tentatively Approved in US For Psoriasis
    Glenmark's Generic Calcipotriene (0.005%) Tentatively Approved in US For Psoriasis

    https://www.pharmacompass.com/pdf/news/n52.pdf

    Press Release FDA
    05 May 2015
    Share Share
    Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.
    Attix Pharmaceuticals Recalls Hundreds of APIs From the U.S.

    http://www.fiercepharmamanufacturing.com/story/attix-pharmaceuticals-recalls-hundreds-apis-us/2015-04-30

    Eric Palmer FIERCE PHARMA MFG
    02 May 2015
    Share Share
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