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    • SOLUTION;INTRAVENOUS - EQ 1MG BASE/10ML (EQ 100MCG BASE/ML)
    • SOLUTION;INTRAVENOUS - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
    • SOLUTION;INTRAVENOUS - EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)
    • SOLUTION;INTRAVENOUS - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
    • INJECTABLE;INJECTION - EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
    • INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
    • INJECTABLE;INJECTION - EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
    • INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
    • INJECTABLE;INJECTION - EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
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    BioXcel Therapeutics Receives Permanent J-Code for IGALMI
    BioXcel Therapeutics Receives Permanent J-Code for IGALMI

    https://www.globenewswire.com//news-release/2023/10/30/2769033/0/en/BioXcel-Therapeutics-Receives-Permanent-J-Code-for-IGALMI-dexmedetomidine-Sublingual-Film-from-Centers-for-Medicare-Medicaid-Services.html

    GLOBENEWSWIRE
    30 Oct 2023
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    BioXcel Provides Update on Recent Developments for IGALMI Film
    BioXcel Provides Update on Recent Developments for IGALMI Film

    https://www.globenewswire.com//news-release/2023/10/04/2754431/0/en/BioXcel-Therapeutics-Provides-Update-on-Recent-Developments-for-Late-Stage-Clinical-Programs-and-Expansion-of-IP-Portfolio-for-IGALMI-dexmedetomidine-Sublingual-Film.html

    GLOBENEWSWIRE
    04 Oct 2023
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    Milla and Alter Announce Yet Another “First Cycle” FDA Approval for Dexmedetomidine Hydrochloride Injection
    Milla and Alter Announce Yet Another “First Cycle” FDA Approval for Dexmedetomidine Hydrochloride Injection

    https://www.businesswire.com/news/home/20230609005336/en

    BUSINESSWIRE
    09 Jun 2023
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    Milla's Generic Dexmedetomidine HydrochlorideReceives Approval in the U.S.
    Milla's Generic Dexmedetomidine HydrochlorideReceives Approval in the U.S.

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217308

    FDA
    07 Jun 2023
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    Intas Pharmaceuticals Limited on FDA Import Alert List
    Intas Pharmaceuticals Limited on FDA Import Alert List

    https://www.accessdata.fda.gov/cms_ia/importalert_189.html

    FDA
    06 Jun 2023
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    Piramal Critical Care Launches First to Market Generic Zinc Sulfate Injection in the U.S.
    Piramal Critical Care Launches First to Market Generic Zinc Sulfate Injection in the U.S.

    https://www.prnewswire.com/news-releases/piramal-critical-care-launches-first-to-market-generic-zinc-sulfate-injection-in-the-us-301608664.html

    PRNEWSWIRE
    19 Aug 2022
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    BioXcel Therapeutics Announces NIH NIDA Grant to Columbia University for BXCL501
    BioXcel Therapeutics Announces NIH NIDA Grant to Columbia University for BXCL501

    https://www.globenewswire.com/news-release/2022/08/01/2489261/0/en/BioXcel-Therapeutics-Announces-NIH-NIDA-Grant-to-Columbia-University-to-Support-Further-Studies-of-BXCL501-Sublingual-Dexmedetomidine-for-Treating-Opioid-Withdrawal.html

    GLOBENEWSWIRE
    01 Aug 2022
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    Psych and neuro R&D notch a win as BioXcel gets FDA approval for dexmedetomidine
    Psych and neuro R&D notch a win as BioXcel gets FDA approval for dexmedetomidine

    https://endpts.com/psych-and-neuro-rd-notch-a-win-as-bioxcel-gets-fda-approval-for-schizophrenia-bipolar-disorder-related-agitation/

    P. Schloesser ENDPTS
    07 Apr 2022
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    Piramal's Generic Dexmedetomidine Hydrochloride Receives Approval in the US
    Piramal's Generic Dexmedetomidine Hydrochloride Receives Approval in the US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214794

    FDA
    03 Sep 2021
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    Dexmedetomidine Ties Propofol for Intubated Adults With Sepsis
    Dexmedetomidine Ties Propofol for Intubated Adults With Sepsis

    https://www.medpagetoday.com/meetingcoverage/sccm/91017

    MEDPAGE
    02 Feb 2021
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    Enforcement Report - Week of December 16, 2020
    Enforcement Report - Week of December 16, 2020

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-16-2020-1608097779.pdf

    FDA
    16 Dec 2020
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    Aurobindo Pharma`s Generic Dexmedetomidine HCl Receives Approval In US
    Aurobindo Pharma`s Generic Dexmedetomidine HCl Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210321

    FDA
    10 Dec 2020
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    Aurobindo Pharma receives USFDA approval for Dexmedetomidine HCL
    Aurobindo Pharma receives USFDA approval for Dexmedetomidine HCL

    https://www.indiainfoline.com/article/news-top-story/aurobindo-pharma-receives-usfda-approval-for-dexmedetomidine-hcl-in-0-9-sodium-chloride-injection-120120900452_1.html

    INDIAINFOLINE
    09 Dec 2020
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    Aurobindo Pharma gets USFDA nod for sedative drug
    Aurobindo Pharma gets USFDA nod for sedative drug

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-pharma-gets-usfda-nod-for-sedative-drug/articleshow/79637842.cms

    ECONOMICTIMES
    08 Dec 2020
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    Tagi`s Generic Dexmedetomidine Hydrochloride Receives Approval In US
    Tagi`s Generic Dexmedetomidine Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212857

    FDA
    26 Nov 2020
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    Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride
    Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride

    https://www.pharmacompass.com/pdf/news/fresenius-kabi-issues-voluntary-nationwide-recall-of-a-single-lot-of-dexmedetomidine-hydrochloride-1606565407.pdf

    FDA
    20 Nov 2020
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    Dexmedetomidine Effectively Sedates Agitated Patients Who Need Ventilation
    Dexmedetomidine Effectively Sedates Agitated Patients Who Need Ventilation

    https://www.firstwordpharma.com/node/1768448?tsid=5

    Nancy Melville FIRSTWORDPHARMA
    26 Oct 2020
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    Dr. Reddy's Announces launch of Dexmedetomidine HCl in 0.9% NaCl Inj. in the US
    Dr. Reddy's Announces launch of Dexmedetomidine HCl in 0.9% NaCl Inj. in the US

    https://www.businesswire.com/news/home/20200925005104/en

    BUSINESSWIRE
    25 Sep 2020
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    Par Sterile Products's Generic Dexmedetomidine HCl Receives Approval In US
    Par Sterile Products's Generic Dexmedetomidine HCl Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208266

    FDA
    17 Sep 2020
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    Enforcement Report - Week of September 2, 2020
    Enforcement Report - Week of September 2, 2020

    https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-2-2020-1599053980.pdf

    FDA
    02 Sep 2020
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    CORRECTING and REPLACING Fresenius Kabi Issues Voluntary Nationwide Recall
    CORRECTING and REPLACING Fresenius Kabi Issues Voluntary Nationwide Recall

    https://www.businesswire.com/news/home/20200722005757/en

    BUSINESSWIRE
    22 Jul 2020
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    BioXcel Announces First Patient Enrolled in Ph 1b/2 RELEASE Trial of BXCL501
    BioXcel Announces First Patient Enrolled in Ph 1b/2 RELEASE Trial of BXCL501

    https://www.globenewswire.com/news-release/2020/06/11/2046758/0/en/BioXcel-Therapeutics-Announces-First-Patient-Enrolled-in-Phase-1b-2-RELEASE-Trial-of-BXCL501-for-the-Treatment-of-Opioid-Withdrawal-Symptoms.html

    GLOBENEWSWIRE
    11 Jun 2020
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    Amneal Pharmaceuticals Generic Buprenorphine Receives Approval in US
    Amneal Pharmaceuticals Generic Buprenorphine Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207551

    FDA
    23 May 2020
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    The FDA approved two abbreviated new drug applications
    The FDA approved two abbreviated new drug applications

    https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-21-2020

    FDA
    22 May 2020
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    FDA Reports More Shortages of Drugs Used to Put COVID-19 Patients on Ventilators
    FDA Reports More Shortages of Drugs Used to Put COVID-19 Patients on Ventilators

    https://www.raps.org/news-and-articles/news-articles/2020/4/fda-reports-more-shortages-of-drugs-used-to-put-co

    Zachary Brennan RAPS
    14 Apr 2020
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    Five meds recommended in final 2019 CHMP meeting
    Five meds recommended in final 2019 CHMP meeting

    http://www.pharmatimes.com/news/five_meds_recommended_in_final_2019_chmp_meeting_1320403

    Anna Smith PHARMA TIMES
    16 Dec 2019
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    EMA’s Meeting highlights from CHMP) recommended five medicines for approval
    EMA’s Meeting highlights from CHMP) recommended five medicines for approval

    https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-9-12-december-2019

    EMA
    14 Dec 2019
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    Slayback Pharma's Generic Dexmedetomidine Hydrochloride Receives Approval in US
    Slayback Pharma's Generic Dexmedetomidine Hydrochloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212791

    FDA
    12 Dec 2019
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    Enforcement Report - Week of May 1, 2019
    Enforcement Report - Week of May 1, 2019

    https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-May-1-2019-1556686753.pdf

    FDA
    01 May 2019
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    Fresenius Kabi's Generic Dexmedetomidine Hydrochloride Receives Approval in US
    Fresenius Kabi's Generic Dexmedetomidine Hydrochloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208129

    FDA
    29 Nov 2018
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    Orion Corp. 's Dexdor (dexmedetomidine HCl) Receives Approval in Europe
    Orion Corp. 's Dexdor (dexmedetomidine HCl) Receives Approval in Europe

    https://www.ema.europa.eu/en/medicines/human/EPAR/dexdor

    EMA
    01 Oct 2018
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    Baxter Healthcare's Generic Dexmedetomidine Hydrochloride Receives Approval in US
    Baxter Healthcare's Generic Dexmedetomidine Hydrochloride Receives Approval in US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208532

    FDA
    23 Aug 2018
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    Zydus Pharm's Generic Dexmedetomidine Hydrochloride Receives Approval In US
    Zydus Pharm's Generic Dexmedetomidine Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206798

    FDA
    28 Feb 2018
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    Precedex® (dexmedetomidine HCL): Baxter Healthcare Corporation v. Hospira
    Precedex® (dexmedetomidine HCL): Baxter Healthcare Corporation v. Hospira

    https://www.pharmacompass.com/pdf/news/precedex-dexmedetomidine-hcl-baxter-healthcare-corporation-v-hospira-1520247044.pdf

    PATENT LITIGATION
    22 Feb 2018
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    PrecedexTM (Dexmedetomidine Hydrochloride): Hospira v. Gland Pharma
    PrecedexTM (Dexmedetomidine Hydrochloride): Hospira v. Gland Pharma

    https://www.pharmacompass.com/pdf/news/precedextm-dexmedetomidine-hydrochloride-hospira-v-gland-pharma-1517811100.pdf

    PATENT LITIGATION
    01 Feb 2018
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    PrecedexTM (Dexmedetomidine Hydrochloride): Hospira v. Jiangsu Hengrui Medicine
    PrecedexTM (Dexmedetomidine Hydrochloride): Hospira v. Jiangsu Hengrui Medicine

    https://www.pharmacompass.com/pdf/news/precedextm-dexmedetomidine-hydrochloride-hospira-v-jiangsu-hengrui-medicine-1517810972.pdf

    PATENT LITIGATION
    01 Feb 2018
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    Teva Pharm’s Generic Dexmedetomidine Hydrochloride Receives Approval In US
    Teva Pharm’s Generic Dexmedetomidine Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205272

    FDA
    29 Nov 2017
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    Precedextm (Dexmedetomidine Hydrochloride): Hospira, Inc. v. Fresenius Kabi USA
    Precedextm (Dexmedetomidine Hydrochloride): Hospira, Inc. v. Fresenius Kabi USA

    https://www.pharmacompass.com/pdf/news/precedextm-dexmedetomidine-hydrochloride-hospira-inc-v-fresenius-kabi-usa-1510550169.pdf

    PATENT LITIGATION
    01 Nov 2017
    Share Share
    Jiangsu Hengrui Med’s Generic Dexmedetomidine Hydrochloride Receives Approval In US
    Jiangsu Hengrui Med’s Generic Dexmedetomidine Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209065

    FDA
    26 Sep 2017
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    Pharmaforce Generic Dexmedetomidine Hydrochloride Receives Approval In US
    Pharmaforce Generic Dexmedetomidine Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203773

    12 May 2017
    Share Share
    West-Ward Pharms Generics Dexmedetomidine Hydrochloride Receives Approval In US
    West-Ward Pharms Generics Dexmedetomidine Hydrochloride Receives Approval In US

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205046

    FDA
    28 Apr 2017
    Share Share
    Actavis's Generic Dexmedetomidine Hcl Approved In US
    Actavis's Generic Dexmedetomidine Hcl Approved In US

    https://www.pharmacompass.com/pdf/news/actaviss-generic-dexmedetomidine-hcl-approved-in-us-1476969954.pdf

    FDA
    19 Oct 2016
    Share Share
    Hq Spclt Pharma's Dexmedetomidine Hydrochloride Approved In US
    Hq Spclt Pharma's Dexmedetomidine Hydrochloride Approved In US

    https://www.pharmacompass.com/pdf/news/hq-spclt-pharmas-dexmedetomidine-hydrochloride-approved-in-us-1474461034.pdf

    FDA
    19 Sep 2016
    Share Share
    Aurobindo gets final USFDA nod for pre-surgery sedation drug
    Aurobindo gets final USFDA nod for pre-surgery sedation drug

    http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-gets-final-usfda-nod-for-pre-surgery-sedation-drug/articleshow/51453728.cms

    ECONOMIC TIMES
    17 Mar 2016
    Share Share
    Accord Hlthcare's Generic Dexmedetomidine Hydrochloride approved in US for intravenous infusion
    Accord Hlthcare's Generic Dexmedetomidine Hydrochloride approved in US for intravenous infusion

    https://www.pharmacompass.com/pdf/news/accord-hlthcares-generic-dexmedetomidine-hcl-approved-in-us-1455705915.pdf

    FDA
    09 Feb 2016
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    Fresenius Kabi's Generic Dexmedetomidine Hydrochloride approved in US as Sedative
    Fresenius Kabi's Generic Dexmedetomidine Hydrochloride approved in US as Sedative

    https://www.pharmacompass.com/pdf/news/fresenius-kabis-generic-dexmedetomidine-hydrochloride-approved-in-us-as-sedative-1443094654.pdf

    FDA
    22 Sep 2015
    Share Share
    Recro Pharma's intranasal pain drug Dex-IN yields positive Phase II results
    Recro Pharma's intranasal pain drug Dex-IN yields positive Phase II results

    http://www.firstwordpharma.com/node/1299982?tsid=28®ion_id=6#axzz3fm2VkTKN

    Lianne Dane FIRST WORD PHARMA
    17 Jul 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
    Otsuka scrambles to persuade judge to block Abilify copycats
    Otsuka scrambles to persuade judge to block Abilify copycats

    http://www.fiercepharma.com/story/otsuka-scrambles-persuade-judge-block-abilify-copycats/2015-04-16

    Tracy Staton FIERCE PHARMA
    17 Apr 2015
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