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  • OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
  • SPRAY, METERED;NASAL - 0.05MG/SPRAY
  • POWDER;INHALATION - 0.05MG/INH
  • POWDER;INHALATION - 0.1MG/INH
  • POWDER;INHALATION - 0.25MG/INH
  • POWDER;INHALATION - 0.03MG/INH
  • POWDER;INHALATION - 0.055MG/INH
  • POWDER;INHALATION - 0.113MG/INH
  • POWDER;INHALATION - 0.232MG/INH
  • POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH
  • POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH
  • POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH
  • POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH
  • POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH
  • POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH
  • LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH
  • AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH
  • AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH
  • AEROSOL, METERED;INHALATION - 0.044MG/INH
  • AEROSOL, METERED;INHALATION - 0.11MG/INH
  • AEROSOL, METERED;INHALATION - 0.22MG/INH

https://www.businesswire.com/news/home/20240416962162/en

BUSINESSWIRE
16 Apr 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-cap-out-of-pocket-inhaler-costs-us-2024-03-20/

REUTERS
21 Mar 2024

https://www.globenewswire.com//news-release/2024/03/15/2847277/0/en/XHANCE-Approved-by-FDA-as-First-and-Only-Medication-Indicated-for-Treatment-of-Adults-with-Chronic-Rhinosinusitis-without-Nasal-Polyps.html

GLOBENEWSWIRE
16 Mar 2024

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-28-2024-59068.pdf

FDA
28 Feb 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-cut-us-prices-advair-valtrex-lamictal-2023-12-22/

REUTERS
23 Dec 2023

https://endpts.com/gsk-looks-to-authorized-generic-version-of-asthma-treatment-flovent-as-medicaid-rebate-caps-lift-next-year/

Lia DeGroot ENDPTS
12 Oct 2023

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

FDA
07 Jun 2023

https://pharmafile.com/news/fda-accepts-snda-for-optinoses-xhance/

Betsy Goodfellow PHARMAFILE
05 May 2023

https://www.globenewswire.com/news-release/2023/02/21/2611944/0/en/Optinose-Submits-Supplemental-New-Drug-Application-for-XHANCE-Label-Expansion.html

GLOBENEWSWIRE
21 Feb 2023

https://endpts.com/drugmakers-benefit-substantially-from-secondary-patents-on-inhalers-report/

Nicole DeFeudis ENDPTS
03 Jan 2023

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

FDA
06 Jul 2022

https://scrip.pharmaintelligence.informa.com/SC146550/Optinose-Looking-For-A-Partner-To-Optimize-Big-Opportunity-In-Chronic-Sinusitis

Jessica Merrill PHARMAINTELLIGENCE
14 Jun 2022

https://www.pharmacompass.com/pdf/news/fda-confirms-para-iv-patent-challenge-for-fluticasone-propionate-inhalation-aerosol-022mcginh-1638776245.pdf

FDA
30 Nov 2021

https://www.globenewswire.com/news-release/2021/10/28/2322547/0/en/Optinose-Completes-Patient-Recruitment-in-Second-Pivotal-Trial-for-XHANCE-in-Chronic-Sinusitis.html

GLOBENEWSWIRE
28 Oct 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-27-2021-1635324993.pdf

FDA
27 Oct 2021

https://www.businesswire.com/news/home/20210521005282/en/Ellodi-Pharmaceuticals-Announces-New-Data-to-Be-Presented-at-Digestive-Disease-Week%C2%AE-2021-with-APT-1011-in-Eosinophilic-Esophagitis

BUSINESSWIRE
21 May 2021

https://www.bloomberg.com/press-releases/2020-09-21/teva-launches-two-digital-inhalers-in-the-u-s-airduo-digihaler-fluticasone-propionate-and-salmeterol-inhalation-powder

BLOOMBERG
21 Sep 2020

https://www.prnewswire.com/news-releases/lannett-signs-agreement-to-be-exclusive-distributor-of-generic-flovent-diskus-301112933.html#:~:text=(NYSE%3A%20LCI)%20today%20announced,covering%20Flovent%20Diskus%20have%20expired.

PRNEWSWIRE
17 Aug 2020

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/cipla-submits-application-with-usfda-for-generic-version-of-asthma-drug/articleshow/75798947.cms

ECONOMICTIMES
18 May 2020

http://www.pharmatimes.com/news/gsk_books_19_sales_growth_for_first_quarter_1339304

Selina McKee PHARMATIMES
29 Apr 2020

https://www.moneycontrol.com/news/business/markets/cipla-share-price-up-8-on-successful-completion-of-phase-3-clinical-study-of-asthma-drug-5104691.html

MONEYCONTROL
02 Apr 2020

https://www.raps.org/news-and-articles/news-articles/2020/3/fda-requires-boxed-warning-for-singulair-generics

Michael Mezher RAPS
05 Mar 2020

https://www.businesswire.com/news/home/20200224005511/en/Teva-Announces-FDA-Approval-ArmonAir%C2%AE-Digihaler%E2%84%A2-fluticasone/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

BUSINESSWIRE
24 Feb 2020

https://njbiz.com/teva-announces-fda-approval-armonair-digihaler-inhalation-powder/

Anthony Vecchione NJBIZ
24 Feb 2020

https://www.fiercepharma.com/pharma/pfizer-bms-gilead-abbvie-and-others-raise-prices-hundreds-medicines-to-ring-2020

E. Sagonowsky FIERCE PHARMA
03 Jan 2020

https://www.fiercepharma.com/pharma/gsk-leaning-respiratory-franchise-shingrix-as-advair-generics-march

Beth Snyder Bulik FIERCE PHARMA
30 Oct 2019

https://www.biopharmadive.com/news/astrazeneca-pt010-fda-rejection-copd-gsk-respiratory-competition/564090/

J.Gardner BIOPHARMADIVE
02 Oct 2019

https://endpts.com/charging-at-blockbuster-advair-novartis-boasts-topline-victories-for-asthma-drugs-in-twin-phiii-studies/

Amber Tong ENDPTS
30 Sep 2019

https://www.raps.org/news-and-articles/news-articles/2019/9/product-hopping-ec-hearing-addresses-restriction

Z. Brennan RAPS
19 Sep 2019

https://endpts.com/the-top-10-franchise-drugs-in-biopharma-history-will-earn-a-total-of-1-4t-trillion-by-2024-what-does-that-tell-us/

John Carroll ENDPTS
16 Aug 2019

https://www.fiercepharma.com/pharma/gsk-holds-firm-despite-advair-generics-thanks-to-new-respiratory-drugs-and-shingrix

Angus Liu FIERCE PHARMA
25 Jul 2019

https://www.fiercepharma.com/pharma/astrazeneca-s-copd-triplet-breztri-rival-to-gsk-s-trelegy-nabs-first-nod-from-japan

Angus Liu FIERCE PHARMA
20 Jun 2019

https://www.reuters.com/article/us-gsk-pharmaceuticals/gsk-pharma-head-flags-need-for-speed-in-high-pressure-drug-market-idUSKCN1TI1TT

Ludwig Burger REUTERS
17 Jun 2019

https://www.fiercebiotech.com/biotech/novartis-asthma-triplet-beats-gsk-s-advair-phase-2-trial

Nick Paul Taylor FIERCE BIOTECH
23 May 2019

https://www.fiercepharma.com/pharma/mylan-investors-have-had-it-management-analysts-say

Eric Sagonowsky FIERCE PHARMA
09 May 2019

https://www.biopharmadive.com/news/generic-advair-hits-gsk-revenues-hard/553868/

Jonathan Gardner BIOPHARMADIVE
01 May 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208024

FDA
19 Apr 2019

https://www.biopharmadive.com/news/mylan-advair-generic-gsk-strong-launch/550093/

BIOPHARMADIVE
08 Mar 2019

https://www.cnbc.com/2019/03/07/biotech-shares-continue-to-fall-on-fda-uncertainty.html

Bertha Coombs CNBC
08 Mar 2019

https://www.cnbc.com/2019/02/27/reuters-america-mylan-shares-sink-as-bleak-profit-outlook-sparks-growth-concerns.html

CNBC
28 Feb 2019

https://www.proactiveinvestors.co.uk/companies/news/215126/ubs-strips-gsk-of-buy-recommendation-on-near-term-fears-for-its-viiv-hiv-division-215126.html

PROACTIVE INVESTOR
23 Feb 2019

https://www.fiercepharma.com/pharma/mylan-s-aggressive-generic-advair-discount-isn-t-as-big-as-it-looks-analysts

Carly Helfand FIERCE PHARMA
14 Feb 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-13-2019-1550065023.pdf

FDA
13 Feb 2019

https://endpts.com/hal-barrons-gsk-team-continues-to-cull-respiratory-drugs-in-big-shift-to-oncology-rd/

John Carroll ENDPTS
06 Feb 2019

https://www.businesswire.com/news/home/20190201005089/en

BUSINESSWIRE
04 Feb 2019

https://www.raps.org/news-and-articles/news-articles/2019/1/mylan-wins-fda-approval-for-first-advair-generic

Ana Mulero RAPS
01 Feb 2019

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm630151.htm

FDA
31 Jan 2019

https://endpts.com/after-a-years-long-reprieve-gsk-is-about-to-see-mylans-generic-carve-into-its-mega-blockbuster-advair-franchise/

John Carroll ENDPTS
31 Jan 2019

https://www.cnbc.com/2019/01/30/fda-approves-mylans-generic-of-advair-asthma-treatment.html

CNBC
31 Jan 2019

http://www.pharmatimes.com/news/ema_approves_flutiform_for_children_with_asthma_1274699

Anna Smith PHARMA TIMES
14 Jan 2019
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