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  • TABLET;ORAL - 150MG;800MG
  • TABLET;ORAL - 150MG
  • TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 600MG
  • TABLET;ORAL - 75MG
  • TABLET;ORAL - 800MG

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202136

FDA
26 Mar 2024

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/zydus-gets-usfda-nod-for-antiviral-drug-used-in-hiv-treatment/articleshow/106020624.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

ECONOMIC TIMES
15 Dec 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-pharma-gets-usfda-nod-for-hiv-drug/articleshow/105586693.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

ECONOMIC TIMES
29 Nov 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206288

FDA
28 Nov 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211578

FDA
28 Nov 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210677

FDA
28 Nov 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210677

FDA
20 Jul 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215389

FDA
05 Jul 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214085

FDA
07 Jun 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/lupin-gets-usfda-nod-for-generic-hiv-drug/articleshow/94639795.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

ECONOMIC TIMES
04 Oct 2022

https://www.bseindia.com/xml-data/corpfiling/AttachLive/cb79b842-3bf4-438d-a183-e6553f9716b0.pdf

BSEINDIA
04 Oct 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215389

FDA
24 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206288

FDA
05 Aug 2022

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-symtuza-210455-darunavir-cobicistat-emtricitabine-tenofovir-alefenamide-80mg-150mg-200mg-10mg-tablets-1633682776.pdf

FDA
06 Oct 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=142512&sid=2

PHARMABIZ
14 Sep 2021

https://www.empr.com/home/news/safety-alerts-and-recalls/counterfeit-hiv-drug-identified-in-three-us-pharmacies/

Diana Ernst, RPh EMPR
28 Dec 2020

https://www.empr.com/home/news/safety-alerts-and-recalls/counterfeit-hiv-drug-identified-in-three-us-pharmacies/

Diana Ernst, RPh EMPR
28 Dec 2020

https://www.jnj.com/lack-of-evidence-to-support-darunavir-based-hiv-treatments-for-coronavirus

PRESS RELEASE
17 Mar 2020

https://www.reuters.com/article/us-healthcare-coronavirus-johnson-johnso/johnson-johnson-says-no-evidence-hiv-drug-works-against-coronavirus-idUSKBN21327V?feedType=RSS&feedName=healthNews

REUTERS
16 Mar 2020

https://cen.acs.org/sections/coronavirus/biological-chemistry/infectious-disease/coronavirus-drug-repurposing.html

Lisa M. Jarvis C&EN
13 Mar 2020

https://www.fiercepharma.com/marketing/j-j-sponsored-film-about-first-aids-ward-san-francisco-picked-up-for-broader-distribution

Beth Snyder Bulik FIERCE PHARMA
10 May 2019

https://endpts.com/going-viral-jj-tries-to-spark-a-twitterstorm-for-the-latest-data-on-its-hiv-med/

John Carroll ENDPTS
13 Apr 2019

https://www.fiercepharma.com/manufacturing/gottlieb-throws-fda-weight-behind-industry-move-to-continuous-manufacturing

Eric Palmer FIERC EPHARMA
27 Feb 2019

https://insight.rpxcorp.com/litigation_documents/13186036

PATENT LITIGATION
20 Dec 2018

http://www.pharmatimes.com/news/nhs_england_agrees_to_fund_janssens_symtuza_1254081

Selina McKee PHARMA TIMES
02 Oct 2018

https://www.biopharmadive.com/news/pharmas-slow-embrace-of-continuous-manufacturing/532811/

Ned Pagliarulo BIOPHARMA DIVE
26 Sep 2018

https://www.biopharmadive.com/news/mercks-virology-business-needs-a-boost-it-may-not-get-that-from-2-new-hiv/531423/

Jacob Bell BIOPHARMADIVE
31 Aug 2018

https://endpts.com/jj-joins-blockbuster-hiv-combo-race-with-newly-approved-4-in-1-pill/

Amber Tong ENDPTS
19 Jul 2018

https://insight.rpxcorp.com/litigation_documents/12928102

PATENT LITIGATION
24 May 2018

https://www.pharmacompass.com/pdf/news/krka-dd-novo-mestos-darunavir-receives-approval-in-europe-1517032602.pdf

EMA
27 Jan 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206288

FDA
18 Dec 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206555

FDA
18 Nov 2017

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/hetero-launches-fdc-combination-of-key-hiv-drugs/articleshow/61644245.cms

DIVYA RAJAGOPAL ECONOMIC TIMES
14 Nov 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/11/news_detail_002844.jsp&mid=WC0b01ac058004d5c1

EMA
11 Nov 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=105094&sid=2

PHARMABIZ
26 Oct 2017

http://www.businesswire.com/news/home/20171025005612/en/Janssen%E2%80%99s-New-Darunavir-Based-Single-Tablet-Regimen-SYMTUZA%C2%AE/?feedref=JjAwJuNHiystnCoBq_hl-WBlLQO14j4QZPTyX5CYOnwC4VjN53jumZRlnzhBoBxGrCOi9QzgjCezTS3Nw_X6kJUrpSBm-Hav1w-UkdSlG3ltkRSnqzf6ourQGu_UA28CzZCGORvG0LE20YOvo49uqw==

BUSINESSWIRE
25 Oct 2017

http://www.prnewswire.com/news-releases/janssen-announces-pivotal-phase-3-study-results-for-investigational-darunavir-based-single-tablet-regimen-for-the-treatment-of-hiv-1-infection-in-adults-switching-from-boosted-protease-inhibitors-plus-emtricitabine-and-tenofovir-d-300532663.html

PR NEWSWIRE
06 Oct 2017

https://www.pharmacompass.com/pdf/news/janssen-cilag-international-generic-symtuza-receives-approval-in-europe-1506487967.pdf

EMA
27 Sep 2017

http://www.prnewswire.com/news-releases/fda-accepts-supplemental-new-drug-application-for-eisais-lenvatinib-for-the-treatment-of-liver-cancer-300526147.html

PR NEWSWIRE
26 Sep 2017

http://www.pharmatimes.com/news/ec_approves_janssens_symtuza_1206421

Adam Hill PHARMA TIMES
26 Sep 2017

https://www.pharmacompass.com/pdf/news/prezista-darunavir-janssen-sciences-ireland-uc-v-aurobindo-pharma-1505212202.pdf

PATENT LITIGATION
07 Sep 2017

http://www.businesswire.com/news/home/20170725005802/en/Janssen-Announces-Phase-3-Pivotal-Study-Results/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

BUSINESSWIRE
25 Jul 2017

http://www.in-pharmatechnologist.com/Processing/EMA-clears-Janssen-to-make-HIV-drug-using-continuous-manufacturing-approach

G. MacDonald IN PHARMATECHNOLOGIST
27 Jun 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206555

FDA
29 Mar 2017

http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

FDA
14 Mar 2017

https://www.pharmacompass.com/pdf/news/mylan-sasgets-eu-nod-for-darunavir-1486203609.pdf

EMA
03 Feb 2017

https://www.pharma-excipients.ch/2016/12/20/encapsulating-darunavir-nanocrystals-within-eudragit-l100-using-coaxial-electrospraying/

PHARMA EXCIPIENTS
20 Dec 2016

http://www.in-pharmatechnologist.com/Processing/Continuous-and-aseptic-innovations-top-US-FDA-list-of-emerging-tech

Dan Stanton IN PHARMATECHNOLOGIST
21 Nov 2016

http://www.pharmatimes.com/news/nine_therapies_put_forward_for_eu_approval_1176576

Selina McKee PHARMATIMES
15 Nov 2016

http://www.in-pharmatechnologist.com/Processing/Thermo-provides-hot-melt-tech-to-US-continuous-manufacturing-researchers

Gareth MacDonald IN PHARMATECHNOLOGIST
14 Nov 2016
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