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  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 2.5MG
  • TABLET;ORAL - 20MG
  • TABLET;ORAL - 5MG
  • TABLET;ORAL - 20MG

https://www.fiercepharma.com/pharma/mercks-key-pah-approval-tap-johnson-johnson-wins-nod-pah-combo-tablet

Kevin Dunleavy FIERCE PHARMA
26 Mar 2024

https://www.prnewswire.com/news-releases/us-fda-approves-opsynvi-macitentan-and-tadalafil-as-the-first-and-only-once-daily-single-tablet-combination-therapy-for-patients-with-pulmonary-arterial-hypertension-pah-302097530.html

PR NEWSWIRE
22 Mar 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218232

FDA
18 Mar 2024

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/today-world-issues-voluntary-nationwide-recall-all-lots-sustain-and-schwinnng-brand-dietary

FDA
05 Feb 2024

https://www.globenewswire.com/news-release/2023/06/26/2694136/0/en/Janssen-Submits-Marketing-Authorisation-Application-to-the-European-Medicines-Agency-EMA-Seeking-Approval-of-Single-Tablet-Combination-Therapy-STCT-of-Macitentan-and-Tadalafil-for-.html

GLOBENEWSWIRE
26 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212515

FDA
06 Jun 2023

https://www.prnewswire.com/news-releases/janssen-submits-new-drug-application-to-us-fda-seeking-approval-of-investigational-single-tablet-combination-therapy-of-macitentan-and-tadalafil-for-treatment-of-patients-with-pulmonary-arterial-hypertension-pah-301834852.html

PR NEWSWIRE
30 May 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-12-2023-46659.pdf

FDA
12 Apr 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-8-2023-15780.pdf

FDA
08 Mar 2023

https://www.fiercepharma.com/pharma/acc23-jjs-combo-pill-opsumit-plus-tadalafil-improves-blood-flow-pah-patients

Kevin Dunleavy FIERCE PHARMA
07 Mar 2023

https://www.prnewswire.com/news-releases/late-breaking-phase-3-a-due-data-show-investigational-single-tablet-combination-therapy-of-macitentan-and-tadalafil-significantly-improves-pulmonary-hemodynamics-versus-monotherapy-in-patients-with-pulmonary-arterial-hypertension--301762855.html

PR NEWSWIRE
06 Mar 2023

https://www.pharmacompass.com/pdf/news/volt-candy-issues-voluntary-nationwide-recall-of-primezen-black-6000-capsules-due-to-presence-of-sildenafil-and-tadalafil-4249.pdf

FDA
13 Feb 2023

https://www.prnewswire.com/news-releases/cmp-pharma-inc-announces-that-tadliq-the-first-and-only-fda-approved-liquid-suspension-of-tadalafil-is-now-available-301656771.html

PRNEWSWIRE
24 Oct 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216932

FDA
12 Oct 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/proper-trade-llcmy-stellar-lifestyle-issues-voluntary-nationwide-recall-wonder-pill-capsules-due

FDA
29 Sep 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210608

FDA
11 Aug 2022

https://www.rttnews.com/3297551/mks-enterprise-recalls-dose-vital-vip-vital-honey.aspx

RTTNEWS
20 Jul 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mks-enterprise-llc-voluntary-recalls-dose-vital-vip-vital-honey-due-presence-undeclared-tadalafil

FDA
18 Jul 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/loud-muscle-science-llc-issues-voluntary-recall-launch-sequence-capsules-due-presence-undeclared

FDA
30 Jun 2022

https://www.statnews.com/2022/06/15/erectile-dysfunction-drug-may-help-men-with-diabetic-heart-damage-not-women/

Akila Muthukumar STATNEWS
15 Jun 2022

https://www.expresspharma.in/us-fda-presses-pause-on-trial-for-otc-version-of-cialis/

EXPRESS PHARMA
31 May 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-02-2022-1646291076.pdf

FDA
02 Mar 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/positive-health-issues-voluntary-nationwide-recall-rise-red-edition-capsules-due-presence-undeclared

FDA
11 Feb 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/celebrate-today-issues-voluntary-nationwide-recall-one-lot-red-mammoth-due-presence-undeclared

FDA
10 Feb 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abc-sales-1-inc-issues-voluntary-nationwide-recall-mac-daddy-red-and-mac-daddy-purple-capsules-due

FDA
09 Feb 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/your-favorite-shop-issues-voluntary-nationwide-recall-red-pill-capsules-due-presence-undeclared

FDA
09 Feb 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/junp-llc-issues-voluntary-nationwide-recall-megman-performance-booster-capsules-due-presence

FDA
05 Feb 2022

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/esupplementsales-llc-issues-nationwide-recall-one-lot-hard-dawn-due-presence-undeclared-tadalafil

FDA
01 Feb 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-17-2021-1637135168.pdf

FDA
17 Nov 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215556

FDA
03 Nov 2021

https://www.globenewswire.com/news-release/2021/09/29/2305793/0/en/IntelGenx-and-Aquestive-Therapeutics-Partner-with-Leading-Men-s-Health-Company-to-Market-Tadalafil-Oral-Films-in-the-U-S.html

GLOBENEWSWIRE
29 Sep 2021

https://www.pharmacompass.com/pdf/news/yamtun7-issues-voluntary-nationwide-recall-of-poseidon-platinum-3500-1620795419.pdf

FDA
12 May 2021

https://ecipharma.com/2021/05/10/eci-pharmaceuticals-llc-signs-agreement-to-be-exclusive-u-s-distributor-of-generic-cialis/

PRESS RELEASE
10 May 2021

https://www.pharmacompass.com/pdf/news/ns-ny-distributor-inc-issues-voluntary-nationwide-recall-of-premium-orgazen-7000-1618506818.pdf

FDA
09 Apr 2021

https://www.pharmacompass.com/pdf/news/adamssecretco-issues-voluntary-nationwide-recall-of-adams-secret-extra-strength-1613545998.pdf

FDA
17 Feb 2021

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-pharma-gets-usfda-nod-for-erectile-dysfunction-treatment/articleshow/80040795.cms

ECONOMIC TIMES
30 Dec 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213496

FDA
26 Nov 2020

https://www.businesswire.com/news/home/20200829005001/en/TRITON-Phase-3b-Study-Results-Presented-European#:~:text=In%20the%20TRITON%20trial%2C%20both,difference%20observed%20between%20both%20groups.

BUSINESSWIRE
31 Aug 2020

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-remedy-store-issues-voluntary-worldwide-recall-active-male-due-presence-undeclared-tadalafil

FDA
17 Mar 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-5-2020-1580878802.pdf

FDA
05 Feb 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208824

FDA
18 Dec 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207290

FDA
18 Oct 2019

https://www.pharmacompass.com/pdf/news/fitoterapia-usa-inc-issues-voluntary-nationwide-recall-of-mero-macho-artificial-passion-fruit-flavored-vitamin-c-liquid-supplement-1568701921.pdf

FDA
17 Sep 2019

https://finance.yahoo.com/news/eli-lilly-tops-profit-estimates-124744250.html

REUTERS
30 Jul 2019

https://www.fiercepharma.com/pharma/xofluza-hand-roche-offloads-tamiflu-u-s-otc-switch-rights-to-sanofi

Angus Liu FIERCE PHARMA
23 Jul 2019

https://www.fiercepharma.com/pharma/sanofi-eisai-join-eli-lilly-s-scotus-bid-to-protect-cialis-patent-bph?utm_source=internal&utm_medium=rss

Kyle Blankenship FIERCE PHARMA
09 Jul 2019

https://www.fiercepharma.com/pharma/eli-lilly-throws-scotus-hail-mary-cialis-patent-infringement-fight

Kyle Blankenship FIERCE PHARMA
07 Jun 2019

https://www.financialexpress.com/industry/dr-reddys-net-profit-up-44-per-cent-in-q4/1581719/

FE Bureau FINANCIAL EXPRESS
17 May 2019

https://www.fiercebiotech.com/research/sheep-study-shows-cialis-might-reverse-heart-failure

Angus Liu FIERCE BIOTECH
03 May 2019
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