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  • POWDER;INTRAMUSCULAR - 11.25MG
  • POWDER;INTRAMUSCULAR - 15MG
  • POWDER;INTRAMUSCULAR - 3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER;INTRAMUSCULAR - 30MG
  • POWDER;INTRAMUSCULAR - 45MG
  • POWDER;INTRAMUSCULAR - 7.5MG
  • POWDER;INTRAMUSCULAR - 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
  • INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-receives-positive-recommendation-from-dsmb-to-continue-the-casppian-study-a-phase-3-clinical-trial-of-leuprolide-fp-001-injectable-emulsion-for-the-treatment-of-central-precocious-puberty-302104381.html

PR NEWSWIRE
01 Apr 2024

https://www.indianpharmapost.com/news/zydus-inks-licensing-agreement-with-daewoong-pharmaceutical-for-leuprolide-injectable-in-the-us-15000

INDIAN PHARMA POST
12 Dec 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-4-2023-22726.pdf

FDA
04 Oct 2023

https://www.prnewswire.com/news-releases/xtandi-enzalutamide-plus-leuprolide-reduced-the-risk-of-metastasis-by-58-in-non-metastatic-hormone-sensitive-prostate-cancer-versus-placebo-plus-leuprolide-301811445.html

PR NEWSWIRE
29 Apr 2023

https://www.fiercepharma.com/pharma/astellas-pfizer-look-broaden-xtandis-patient-base-new-prostate-cancer-win-after-8-years

FIERCE PHARMA
18 Mar 2023

https://www.prnewswire.com/news-releases/peptrons-pt105-a-sustained-release-leuprolide-established-the-bioequivalence-with-takedas-leuplin-301687409.html

PRNEWSWIRE
28 Nov 2022

https://www.businesswire.com/news/home/20221102005185/en

BUSINESSWIRE
02 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215336

FDA
28 Oct 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212963

FDA
06 Jun 2022

https://www.prnewswire.com/news-releases/accord-biopharma-in-partnership-with-foresee-pharmaceuticals-launches-camcevi-leuprolide-injection-emulsion-in-the-us-for-the-treatment-of-advanced-prostate-cancer-in-adults-301516986.html

PRNEWSWIRE
04 Apr 2022

https://www.fiercepharma.com/pharma/takeda-guilty-breach-contract-spat-abbvie-over-supply-problems-prostate-cancer-drug-lupron

Kevin Dunleavy FIERCEPHARMA
24 Sep 2021

https://www.fiercepharma.com/pharma/no-dice-court-tells-abbvie-it-can-t-force-takeda-to-supply-a-drug-s-short-supply-worldwide

Eric Sagonowsky FIERCEPHARMA
09 Sep 2021

https://www.prnewswire.com/news-releases/tolmar-publishes-fensolvi--leuprolide-acetate-for-injectable-suspension-safety-and-efficacy-data-in-journal-of-clinical-endocrinology-and-metabolism-301179761.html

PRNEWSWIRE
24 Nov 2020

https://www.prnewswire.com/news-releases/tolmar-affirms-supply-of-fensolvi-leuprolide-acetate-for-pediatric-patients-with-central-precocious-puberty-301114208.html#:~:text=BUFFALO%20GROVE%2C%20Ill.%2C%20Aug,central%20precocious%20puberty%20(CPP).

PRNEWSWIRE
18 Aug 2020

https://www.prnewswire.com/news-releases/tolmar-affirms-full-supply-of-eligard-leuprolide-acetate-for-injectable-suspension-for-the-palliative-management-of-advanced-prostate-cancer-301109379.html

PRNEWSWIRE
10 Aug 2020

https://www.fiercepharma.com/manufacturing/takeda-hustles-to-prevent-cancer-drug-shortage-after-fda-warning-letter

Tracy Staton FIERCE PHARMA
07 Aug 2020

https://www.prnewswire.com/news-releases/early-treatment-linked-to-reduced-joint-damage-in-young-adults-with-severe-hemophilia-a-301070219.html

PRNEWSWIRE
03 Jun 2020

https://www.ema.europa.eu/en/news/leuprorelin-depot-medicines-prac-recommends-new-measures-avoid-handling-errors

EMA
15 May 2020

https://www.fiercebiotech.com/biotech/myovant-s-oral-prostate-cancer-drug-matches-incumbent-phase-3

N. P Taylor FIERCE BIOTECH
20 Nov 2019

https://www.fiercebiotech.com/biotech/myovant-s-oral-prostate-cancer-drug-matches-incumbent-phase-3

N. P Taylor FIERCE BIOTECH
20 Oct 2019

https://www.fiercebiotech.com/biotech/myovant-s-oral-prostate-cancer-drug-matches-incumbent-phase-3

N. P Taylor FIERCE BIOTECH
20 Oct 2019

https://www.clinicaltrialsarena.com/news/su2c-clinical-trials-teams-launch/

CLINEICALTRIALSARENA
18 Sep 2019

https://www.federalregister.gov/documents/2019/05/30/2019-11243/determination-that-lupron-leuprolide-acetate-injection-1-milligram02-milliliter-was-not-withdrawn

FEDERAL REGISTER
30 May 2019

https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-enters-exclusive-license-agreement-with-accord-healthcare-300792989.html

PR NEWSWIRE
11 Feb 2019

https://www.prnewswire.com/news-releases/enteris-biopharma-announces-positive-results-from-expanded-phase-2a-clinical-trial-of-ovarest-oral-leuprolide-tablet-for-endometriosis-300672192.html

PR NEWSWIRE
26 Jun 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-may-16-2018-1526446624.pdf

FDA
16 May 2018

https://www.prnewswire.com/news-releases/enteris-biopharma-announces-completion-of-recruitment-in-expanded-phase-2a-clinical-trial-of-ovarest-oral-leuprolide-tablet-for-endometriosis-300638439.html

PR NEWSWIRE
30 Apr 2018

https://www.aspenapi.com/edqm-has-granted-a-cep-for-leuprorelin/

PRESS RELEASE
03 Oct 2017

https://www.statnews.com/2017/02/02/lupron-puberty-children-health-problems/

C JEWETT STAT
03 Feb 2017

http://www.fiercebiotech.com/biotech/enteris-biopharma-signs-oral-diabetes-pact-sanofi

Ben Adams FIERCE BIOTECH
24 Jan 2017

http://www.pmlive.com/pharma_news/allergan_plans_to_file_oral_uterine_fibroid_drug_in_us_by_year-end_1184383

Phil Taylor PMLIVE
17 Jan 2017

http://www.fiercebiotech.com/biotech/myovant-bumps-up-ipo-to-218m-pfizer-bb-biotech-aid

Stacy Lawrence FIERCE BIOTECH
28 Oct 2016

http://www.fiercepharmamanufacturing.com/story/drug-shortages-becomes-issue-teva-and-mylan-hook/2015-04-30

Eric Palmer FIERCE PHARMA MANUFACTURING
30 Apr 2015
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