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  • FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION
  • GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TRANSDERMAL - 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TRANSDERMAL - 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • GEL;TRANSDERMAL - 50MG/5GM PACKET
  • TABLET, EXTENDED RELEASE;BUCCAL - 30MG
  • GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION)
  • GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-6-2023-46648.pdf

FDA
06 Dec 2023

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

FDA
12 Apr 2023

https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=print.getPrintData&ts=11202310416

FDA
01 Feb 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-3-2022-1659944441.pdf

FDA
03 Aug 2022

https://health.economictimes.indiatimes.com/news/pharma/bayer-to-sell-testosterone-drug-for-up-to-500-mn-euros/92874949

ET HEALTH
15 Jul 2022

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fagron-group-bv-624255-06142022

FDA
29 Jun 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-01-2022-1654158193.pdf

FDA
01 Jun 2022

https://www.globenewswire.com/news-release/2022/02/24/2391609/0/en/Testosterone-Injections-Free-New-Step-By-Step-Guide-From-Secrets-of-Bodybuilding.html

GLOBENEWSWIRE
24 Feb 2022

https://www.prnewswire.com/news-releases/lipocine-announces-peer-reviewed-publication-of-phase-3-study-results-for-tlando-301469292.html

PRNEWSWIRE
27 Jan 2022

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

FDA
17 Nov 2021

https://www.globenewswire.com/news-release/2021/10/14/2314390/19989/en/Clarus-Therapeutics-to-Present-New-Real-World-Experience-Data-for-JATENZO-testosterone-undecanoate-at-the-22nd-Annual-Fall-Scientific-Meeting-of-SMSNA.html

GLOBENEWSWIRE
14 Oct 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209836

FDA
03 Sep 2021

https://www.law360.com/lifesciences/articles/1410220?utm_source=rss&utm_medium=rss&utm_campaign=section

Mike Curley LAW360
06 Aug 2021

https://www.reuters.com/business/healthcare-pharmaceuticals/us-supreme-court-rebuffs-abbvie-appeal-patent-fight-involving-androgel-drug-2021-06-21/

REUTERS
21 Jun 2021

https://www.expresspharma.in/aleor-dermaceuticals-gets-usfda-nod-for-testosterone-topical-solution/

EXPRESSPHARMA
15 Jun 2021

https://www.prnewswire.com/news-releases/tolmar-publishes-study-in-the-february-issue-of-journal-of-urology-on-the-impact-of-late-dosing-on-testosterone-suppression-with-two-different-leuprolide-acetate-formulations-in-situ-gel-and-microsphere--an-analysis-of-us-clinic-301266673.html

PRNESWIRE
13 Apr 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214689

FDA
08 Mar 2021

https://www.expresspharma.in/market-pharma/aleor-dermaceuticals-gets-usfda-final-nod-for-testosterone-gel/

EXPRESSPHARMA
04 Mar 2021

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharmas-jv-aleor-dermaceuticals-gets-us-regulators-nod-for-testosterone-gel/articleshow/81326371.cms

INDIATIMES
04 Mar 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212301

FDA
20 Jan 2021

https://www.globenewswire.com/fr/news-release/2020/12/07/2140624/0/en/Clarus-Announces-JATENZO-Testosterone-Undecanoate-Capsules-CIII-Now-Covered-by-Express-Scripts.html#:~:text=r%C3%A9glementaires%20Partenaires%20m%C3%A9dias-,Clarus%20Announces%20JATENZO%C2%AE%20(Testosterone%20Undecanoate)%20Capsules%2C%20CIII,Now%20Covered%20by%20Express%20Scripts&text=07%20d%C3%A9c.%202020%2009h00%20HE,Source%20%3A%20Clarus%20Therapeutics%2C%20Inc.&text=As%20of%20December%201%2C%202020,the%20addition%20of%20Express%20Scripts.

GLOBENEWSWIRE
07 Dec 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209181

FDA
28 Nov 2020

https://medicircle.in/alembic-pharmaceuticals-announces-its-joint-venture-aleor-dermaceuticals-receives-usfda-tentative-approval-for-testosterone-gel

IN
25 Nov 2020

https://www.businesswire.com/news/home/20200720005031/en/Acerus-Announces-Launch-NATESTO%C2%AE-Specialty-Sales-Team#:~:text=TORONTO%2D%2D(BUSINESS%20WIRE)%2D%2D,key%20product%2C%20NATESTO%C2%AE%20(testosterone

BUSINESSWIRE
20 Jul 2020

https://www.businesswire.com/news/home/20200603005230/en

BUSINESSWIRE
02 Jun 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210835

FDA
21 Apr 2020

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

FDA
05 Feb 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-22-2020-1579699881.pdf

FDA
22 Jan 2020

https://www.businesswire.com/news/home/20200110005100/en

BUSINESS WIRE
10 Jan 2020

https://endpts.com/in-crowded-prostate-cancer-market-pfizers-xtandi-notches-third-approval-for-use-in-earlier-stage-of-disease/

N. Grover ENDPT NEWS
18 Dec 2019

https://www.businesswire.com/news/home/20191202005215/en

BUSINESS WIRE
02 Dec 2019

https://www.businesswire.com/news/home/20191023005199/en

BUSINESSWIRE
23 Oct 2019

https://www.reuters.com/article/us-health-running-testosterone-women/boosting-womens-testosterone-can-increase-muscle-mass-and-endurance-idUSKBN1WW2ZK

Linda Carroll REUTERS
18 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209390

FDA
23 Sep 2019

https://www.pharmacompass.com/pdf/news/health-canada-issues-recall-of-acerus-pharmaceuticals-corporation-natesto-gel-1566017095.pdf

HEALTH CANADA
14 Aug 2019

https://www.pharmacompass.com/pdf/news/asclemed-usa-inc-receives-fda-warning-letter-1562147954.pdf

FDA
03 Jul 2019

https://in.reuters.com/article/us-health-prostatecancer-dementia/risk-of-dementia-rises-with-prostate-cancer-hormone-blocking-therapy-idINKCN1TY2VD?feedType=RSS&feedName=health

Linda Carroll REUTERS
03 Jul 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-19-2019-1560925761.pdf

FDA
19 Jun 2019

https://www.pharmacompass.com/pdf/news/pharm-d-solutions-llc-issues-voluntary-nationwide-recall-of-all-sterile-compounded-drugs-due-to-a-potential-lack-of-sterility-assurance-1558768382.pdf

FDA
23 May 2019

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-launches-generic-testosterone-gel-in-us-market/articleshow/69198308.cms

ECONOMIC TIMES
06 May 2019

https://www.moneycontrol.com/news/business/markets/lupin-gains-2-as-co-launches-testosterone-gel-in-us-3814031.html

MONEYCONTROL
11 Apr 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-27-2019-1553661457.pdf

FDA
27 Mar 2019

https://www.businesswire.com/news/home/20190228005305/en/Innovus-Pharma-Announces-Approval-BH%E2%84%A2-Testosterone-Booster/?feedref=JjAwJuNHiystnCoBq_hl-bQQCakZDujohEJegUyaJwquReQ0P23MrIoWkrUSV24ZevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxbNWfZlBntHS6jpH5ROLXsTFMkl05DM8ABqeyBleEmzJA==

BUSINESSWIRE
28 Feb 2019

https://www.prnewswire.com/news-releases/lipocine-inc-announces-fda-clearance-of-ind-to-commence-phase-2-study-of-lpcn-1144-in-biopsy-confirmed-nash-subjects-300795481.html

PR NEWSWIRE
15 Feb 2019

https://www.prnewswire.com/news-releases/sojournix-announces-positive-top-line-phase-1-data-demonstrating-clinical-proof-of-mechanism-and-once-daily-qd-pharmacokinetics-for-sjx-653-300794284.html

PR NEWSWIRE
13 Feb 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-6-2019-1549474146.pdf

FDA
06 Feb 2019

https://www.prnewswire.com/news-releases/uspto-grants-priority-motion-to-lipocine-and-enters-judgment-against-clarus-300776981.html

PR NEWSWIRE
14 Jan 2019

https://uk.reuters.com/article/us-health-men-testosterone/doctors-still-prescribing-testosterone-to-men-with-heart-disease-despite-risks-idUKKCN1OR1HH?rpc=401&

Linda Carroll REUTERS
28 Dec 2018

https://www.prnewswire.com/news-releases/astellas-and-pfizer-announce-positive-top-line-results-from-phase-3-arches-trial-of-xtandi-enzalutamide-in-men-with-metastatic-hormone-sensitive-prostate-cancer-300769270.html

PR NEWSWIRE
20 Dec 2018

https://www.pharmacompass.com/pdf/news/hybrid-pharma-receives-fda-warning-letter-1549703483.pdf

FDA
12 Dec 2018
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