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  • FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
  • FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
  • FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
  • SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)
  • TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)
  • FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
  • FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
  • FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
  • FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

https://www.globenewswire.com/news-release/2023/08/30/2734110/33240/en/Emergent-BioSolutions-NARCAN-Nasal-Spray-Launches-Over-the-Counter-Making-it-Possible-for-Everyone-to-Help-Save-a-Life-from-an-Opioid-Overdose-Emergency.html

GLOBENEWSWIRE
30 Aug 2023

https://www.prnewswire.com/news-releases/wexler-boley--elgersma-llp-miller-law-llc-hilliard-shadowen-llp-motley-rice-llc-and-spector-roseman--kodroff-pc-announce-a-30-million-class-action-settlement-for-those-who-may-have-purchased-or-provided-reimbursement-for--301910202.html

PR NEWSWIRE
28 Aug 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214737

FDA
11 Aug 2023

https://endpts.com/otc-naloxone-nasal-spray-to-cost-about-as-much-as-the-brand-name-prescription-version/

Zachary Brennan ENDPTS
09 Aug 2023

https://www.prnewswire.com/news-releases/orexo-wins-patent-litigation-for-zubsolv-in-the-us-301868534.html

PR NEWSWIRE
01 Jul 2023

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

FDA
07 Jun 2023

https://www.businesswire.com/news/home/20230427005905/en

BUSINESSWIRE
27 Apr 2023

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-naloxone-hydrochloride-68321.pdf

FDA
25 Apr 2023

https://www.globenewswire.com/news-release/2023/03/31/2639055/0/en/Heart-to-Heart-CPR-Now-Offering-Free-Naloxone-Kits-and-Opioid-Response-Training-to-Communities-Most-in-Need.html

GLOBENEWSWIRE
31 Mar 2023

https://www.fiercepharma.com/manufacturing/emergent-makes-history-first-fda-nod-over-counter-naloxone

Fraiser Kansteiner FIERCE PHARMA
30 Mar 2023

https://www.accesswire.com/viewarticle.aspx?id=742570&lang=en

ACCESSWIRE
08 Mar 2023

https://www.businesswire.com/news/home/20230302005110/en

BUSINESSWIRE
02 Mar 2023

https://www.fiercepharma.com/pharma/ahead-next-months-fda-decision-emergent-aces-adcom-over-counter-narcan

Fraiser Kansteiner FIERCE PHARMA
16 Feb 2023

https://endpts.com/should-narcan-spray-be-sold-over-the-counter-fda-poses-potential-packaging-changes/

Nicole DeFeudis ENDPTS
13 Feb 2023

https://www.fiercepharma.com/pharma/orexo-leveraging-drug-delivery-tech-seeks-fda-approval-nasal-high-dose-opioid-rescue

Nick Paul Taylor FIERCE PHARMA
08 Feb 2023

https://www.prnewswire.com/news-releases/harm-reduction-therapeutics-new-drug-application-for-rivive-over-the-counter-naloxone-nasal-spray-accepted-and-granted-priority-review-by-fda-301710002.html

PRNEWSWIRE
26 Dec 2022

https://www.biospace.com/article/releases/emergent-biosolutions-announces-u-s-fda-acceptance-and-priority-review-of-supplemental-new-drug-application-for-over-the-counter-narcan-naloxone-hcl-nasal-spray/

BIOSPACE
07 Dec 2022

https://www.globenewswire.com//news-release/2022/12/06/2568056/33240/en/Emergent-BioSolutions-Announces-U-S-FDA-Acceptance-and-Priority-Review-of-Supplemental-New-Drug-Application-for-Over-the-Counter-NARCAN-naloxone-HCl-Nasal-Spray.html

GLOBENEWSWIRE
06 Dec 2022

https://www.wsj.com/articles/opioid-overdose-naloxone-over-the-counter-11669859905

Julie Wernau WSJ
02 Dec 2022

https://www.prnewswire.com/news-releases/naxswab-otc-novel-naloxone-nasal-swab-demonstrates-faster-absorption-and-higher-early-exposures-against-other-naloxone-products-in-clinical-study-301691438.html

PRNEWSWIRE
01 Dec 2022

https://www.prnewswire.com/news-releases/fda-announces-preliminary-assessment-that-certain-naloxone-products-have-the-potential-to-be-safe-and-effective-for-over-the-counter-use-301678741.html

PRNEWSWIRE
15 Nov 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-9-2022-56129.pdf

FDA
09 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214792

FDA
07 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216624

FDA
26 Oct 2022

https://firstwordpharma.com/story/5666169

FIRSTWORDPHARMA
20 Oct 2022

https://www.prnewswire.com/news-releases/over-the-counter-naloxone-one-step-closer-as-harm-reduction-therapeutics-initiates-a-rolling-submission-of-its-new-drug-application-nda-to-us-food-and-drug-administration-for-rivive-3-0-mg-intranasal-naloxone-for-emergency--301645959.html

PRNEWSWIRE
11 Oct 2022

https://www.fda.gov/news-events/fda-voices/fda-issues-new-guidance-help-facilitate-availability-naloxone-prevent-opioid-overdoses-and-reduce

FDA
23 Sep 2022

https://www.raps.org/news-and-articles/news-articles/2022/9/fda-exempts-naloxone-distribution-from-dscsa-track

Joanne S. Eglovitch RAPS
23 Sep 2022

https://www.businesswire.com/news/home/20220831005683/en

BUSINESSWIRE
31 Aug 2022

https://endpts.com/indivior-fails-to-escape-class-action-lawsuit-in-suboxone-case/

Nicole DeFeudis ENDPTS
24 Aug 2022

https://www.prnewswire.com/news-releases/harm-reduction-therapeutics-signs-commercial-supply-agreement-for-fast-tracked-naloxone-nasal-spray-to-reverse-opioid-overdoses-301603546.html

PRNEWSWIRE
11 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215964

FDA
29 Jul 2022

https://www.businesswire.com/news/home/20220707005189/en

BUSINESSWIRE
07 Jul 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211951

FDA
21 Jun 2022

https://padagis.com/padagis-announces-3-major-product-launches/

FDA
21 Jun 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212300

FDA
10 Jun 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213843

FDA
09 Jun 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212756

FDA
02 Jun 2022

https://www.globenewswire.com/news-release/2022/04/27/2430661/37234/en/Opiant-Pharmaceuticals-Announces-Positive-Topline-Results-from-Head-to-Head-Pharmacodynamic-Study-Comparing-OPNT003-Nasal-Nalmefene-to-Nasal-Naloxone.html

GLOBENEWSWIRE
27 Apr 2022

https://www.statnews.com/pharmalot/2022/04/13/bluebird-gene-therapy-blood-disorder/

E. Silverman STATNEWS
14 Apr 2022

https://endpts.com/purdue-shells-out-a-little-more-cash-for-a-non-profit-biotech-working-on-naloxone-otc-nasal-spray/

P. Scloesser ENDPTS
30 Mar 2022

https://www.businesswire.com/news/home/20220323005621/en

BUSINESSWIRE
23 Mar 2022

https://www.businesswire.com/news/home/20220302005211/en

BUSINESSWIRE
02 Mar 2022

https://www.prnewswire.com/news-releases/harm-reduction-therapeutics-announces-that-its-naloxone-nasal-spray-met-its-primary-endpoints-in-a-phase-1-clinical-trial-301492746.html

PRNEWSWIRE
01 Mar 2022

https://www.prnewswire.com/news-releases/orexos-lead-product-zubsolv-added-to-ny-state-medicaid-mat-preferred-drug-list-301489356.html

PRNEWSWIRE
24 Feb 2022

https://www.businesswire.com/news/home/20211222005564/en

BUSINESSWIRE
22 Dec 2021

http://www.pharmafile.com/news/595850/orexo-s-new-drug-effective-against-opioid-overdoses

PHARMAFILE
16 Nov 2021

https://www.prnewswire.com/news-releases/orexo-announces-positive-results-from-pivotal-trial-for-its-leading-pharmaceutical-pipeline-asset-ox124-301425001.html

PRNEWSWIRE
16 Nov 2021

https://endpts.com/kaleo-to-pay-out-more-than-12m-in-false-claims-case-regarding-high-price-drug-urogen-gets-ready-to-start-phiii-cancer-trial/

Paul Schloesser ENDPTS
11 Nov 2021

https://www.prnewswire.com/news-releases/hikma-donates-50-000-doses-of-injectable-naloxone-to-help-expand-non-profit-access-to-lifesaving-treatment-for-reversing-opioid-overdoses-301406485.html

PRNEWSWIRE
22 Oct 2021
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