OTC-BB:ENDPQ

Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution

Retrieved on: 
Tuesday, March 12, 2024
Online, Endo International, Brain, Exercise, Blood, Patient, Knowledge, Travel, Stroke, Hospital, Par, Prostacyclin, Death, Particulates, NDC, Orthostatic hypertension, Completeness, Heart, Water, Administration, FDA, Swelling, Food

The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Key Points: 
  • The product is being recalled due to the potential for the presence of silicone particulates in the product solution.
  • Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material.
  • Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01.
  • If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

Endo Reaches Resolution with U.S. Department of Justice Regarding Legacy Marketing of Opana® ER

Retrieved on: 
Thursday, February 29, 2024
Ethics, OTC, Marketing, Corporate action, Culture, Internal Revenue Service, Endo International, DOJ, United States bankruptcy court, Average revenue per user, Cosmetic, Pharmaceutical industry

DUBLIN, Feb. 29, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) ("Endo" or the "Company") today announced that its subsidiary, Endo Health Solutions Inc. ("EHSI"), has agreed to resolve all issues regarding previously disclosed U.S. Department of Justice ("DOJ") investigations of EHSI and other Company subsidiaries related to certain legacy marketing of Opana® ER. The Company voluntarily stopped marketing Opana® ER directly to U.S. healthcare providers in 2016 and stopped selling Opana® ER in 2017.

Key Points: 
  • DUBLIN, Feb. 29, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) ("Endo" or the "Company") today announced that its subsidiary, Endo Health Solutions Inc. ("EHSI"), has agreed to resolve all issues regarding previously disclosed U.S. Department of Justice ("DOJ") investigations of EHSI and other Company subsidiaries related to certain legacy marketing of Opana® ER.
  • The Company voluntarily stopped marketing Opana® ER directly to U.S. healthcare providers in 2016 and stopped selling Opana® ER in 2017.
  • EHSI also agreed to resolve the DOJ's civil investigation of the sales and marketing of Opana® ER.
  • Endo submitted the DOJ resolutions to the Bankruptcy Court for approval, which Endo is seeking in conjunction with its proposed Plan of Reorganization.

Endo Reaches Resolution with U.S. Department of Justice Regarding Legacy Marketing of Opana® ER

Retrieved on: 
Thursday, February 29, 2024
Ethics, OTC, Marketing, Corporate action, Culture, Internal Revenue Service, Endo International, DOJ, United States bankruptcy court, Average revenue per user, Cosmetic, Pharmaceutical industry

DUBLIN, Feb. 29, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) ("Endo" or the "Company") today announced that its subsidiary, Endo Health Solutions Inc. ("EHSI"), has agreed to resolve all issues regarding previously disclosed U.S. Department of Justice ("DOJ") investigations of EHSI and other Company subsidiaries related to certain legacy marketing of Opana® ER. The Company voluntarily stopped marketing Opana® ER directly to U.S. healthcare providers in 2016 and stopped selling Opana® ER in 2017.

Key Points: 
  • DUBLIN, Feb. 29, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) ("Endo" or the "Company") today announced that its subsidiary, Endo Health Solutions Inc. ("EHSI"), has agreed to resolve all issues regarding previously disclosed U.S. Department of Justice ("DOJ") investigations of EHSI and other Company subsidiaries related to certain legacy marketing of Opana® ER.
  • The Company voluntarily stopped marketing Opana® ER directly to U.S. healthcare providers in 2016 and stopped selling Opana® ER in 2017.
  • EHSI also agreed to resolve the DOJ's civil investigation of the sales and marketing of Opana® ER.
  • Endo submitted the DOJ resolutions to the Bankruptcy Court for approval, which Endo is seeking in conjunction with its proposed Plan of Reorganization.

Endo Announces Publication of New XIAFLEX® (collagenase clostridium histolyticum) Survey Data in Journal of Hand Surgery Global Open

Retrieved on: 
Wednesday, January 24, 2024
Consensus, Patient, Hand, Capsular contracture, Health care, Collagenase clostridium histolyticum, Contracture, Disability, PIP, Endo International, OTC, Dupuytren's contracture, Treatment, MP, Dentistry

DUBLIN, Jan. 24, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the peer-reviewed Journal of Hand Surgery Global Open published Collagenase Clostridium Histolyticum for the Treatment of Dupuytren Disease: A Delphi-Based Consensus Study .1

Key Points: 
  • DUBLIN, Jan. 24, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the peer-reviewed Journal of Hand Surgery Global Open published Collagenase Clostridium Histolyticum for the Treatment of Dupuytren Disease: A Delphi-Based Consensus Study .1
    Consensus-based study findings among expert hand surgeons indicate that XIAFLEX® (collagenase clostridium histolyticum) has a wide-ranging application for the appropriate treatment of Dupuytren's contracture in patients with varying degrees of disease severity and functional impairment.
  • Results from the published research indicate a high level of consensus for using XIAFLEX for the treatment of one- or two-finger metacarpophalangeal (MP) joint contractures, most one- or two-finger proximal interphalangeal (PIP) joint contractures, and most combined MP and PIP joint contractures.
  • "Healthcare providers and patients can choose among multiple surgical and nonsurgical treatment options for Dupuytren's disease, and without established guidelines, the process for sorting through those choices can be overwhelming," said Dr. Gary M. Pess, a hand and upper extremity surgeon and lead author of the study.
  • "This study provides insight from experienced hand surgeons about using XIAFLEX to treat varying degrees of Dupuytren's contracture."

Endo Announces Publication of New XIAFLEX® (collagenase clostridium histolyticum) Survey Data in Journal of Hand Surgery Global Open

Retrieved on: 
Wednesday, January 24, 2024
Consensus, Patient, Hand, Capsular contracture, Health care, Collagenase clostridium histolyticum, Contracture, Disability, PIP, Endo International, OTC, Dupuytren's contracture, Treatment, MP, Dentistry

DUBLIN, Jan. 24, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the peer-reviewed Journal of Hand Surgery Global Open published Collagenase Clostridium Histolyticum for the Treatment of Dupuytren Disease: A Delphi-Based Consensus Study .1

Key Points: 
  • DUBLIN, Jan. 24, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the peer-reviewed Journal of Hand Surgery Global Open published Collagenase Clostridium Histolyticum for the Treatment of Dupuytren Disease: A Delphi-Based Consensus Study .1
    Consensus-based study findings among expert hand surgeons indicate that XIAFLEX® (collagenase clostridium histolyticum) has a wide-ranging application for the appropriate treatment of Dupuytren's contracture in patients with varying degrees of disease severity and functional impairment.
  • Results from the published research indicate a high level of consensus for using XIAFLEX for the treatment of one- or two-finger metacarpophalangeal (MP) joint contractures, most one- or two-finger proximal interphalangeal (PIP) joint contractures, and most combined MP and PIP joint contractures.
  • "Healthcare providers and patients can choose among multiple surgical and nonsurgical treatment options for Dupuytren's disease, and without established guidelines, the process for sorting through those choices can be overwhelming," said Dr. Gary M. Pess, a hand and upper extremity surgeon and lead author of the study.
  • "This study provides insight from experienced hand surgeons about using XIAFLEX to treat varying degrees of Dupuytren's contracture."

Endo Launches Unscripted Video Series With Real Peyronie's Disease Patients

Retrieved on: 
Thursday, November 30, 2023
Endo International, PD, History, Patient, Embarrassment, FDA, Peyronie's disease, Penis, Fear, Urethra, Health, Diagnosis, Confusion, OTC, Palladium

DUBLIN, Nov. 30, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today the launch of its new branded video series, PD Pool Hall, which aims to educate people about Peyronie's disease (PD), a men's health condition that is estimated to affect 1 in 10 men in the U.S.* and can lead to a curvature deformity of the penis when erect.

Key Points: 
  • The PD Pool Hall videos feature four real patients, both treated and untreated, in a pool hall discussing their experiences with PD, including the impact on their lives and their treatment journeys.
  • The conversations are unscripted and present the patients' actual views and stories.
  • "The men in the videos know firsthand the confusion, embarrassment and even fear that men may face along the PD journey," Mattice continued.
  • The videos are viewable on Endo's newly redesigned consumer website for XIAFLEX, found at XIAFLEX.com .

Endo Launches Unscripted Video Series With Real Peyronie's Disease Patients

Retrieved on: 
Thursday, November 30, 2023
Endo International, PD, History, Patient, Embarrassment, FDA, Peyronie's disease, Penis, Fear, Urethra, Health, Diagnosis, Confusion, OTC, Palladium

DUBLIN, Nov. 30, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today the launch of its new branded video series, PD Pool Hall, which aims to educate people about Peyronie's disease (PD), a men's health condition that is estimated to affect 1 in 10 men in the U.S.* and can lead to a curvature deformity of the penis when erect.

Key Points: 
  • The PD Pool Hall videos feature four real patients, both treated and untreated, in a pool hall discussing their experiences with PD, including the impact on their lives and their treatment journeys.
  • The conversations are unscripted and present the patients' actual views and stories.
  • "The men in the videos know firsthand the confusion, embarrassment and even fear that men may face along the PD journey," Mattice continued.
  • The videos are viewable on Endo's newly redesigned consumer website for XIAFLEX, found at XIAFLEX.com .

Endo Announces Five Presentations at the Sexual Medicine Society of North America (SMSNA) Annual Meeting

Retrieved on: 
Thursday, November 16, 2023
CCH, Post hoc analysis, User experience, Randomness, PD, Endo International, Collagenase clostridium histolyticum, Data analysis, Peyronie's disease, Control, Penile pain, Patient, OTC, Prior, Entamoeba histolytica, Pharmaceutical industry

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.

Key Points: 
  • DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.
  • "The relatively common condition of Peyronie's disease—estimated to affect 1 in 10 men in the U.S.—remains under-studied and is often misunderstood," said Dr. Jesse Mills, urologist and presenter of the data analysis poster.
  • "Efforts like the post hoc analysis of XIAFLEX® Phase 3 data and the new landmark registry aim to advance medical knowledge of PD and support patient outcomes."
  • The five new Endo-sponsored and Endo-supported presentations are below:
    Peyronie's Disease Patients with Penile Pain at Baseline Treated with Collagenase Clostridium Histolyticum: A Post Hoc Analysis
    Outcomes of Collagenase Clostridium Histolyticum in Men with Ventral Curvatures: An Updated Series
    Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
    Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 1 Year Outcomes

Endo Announces Five Presentations at the Sexual Medicine Society of North America (SMSNA) Annual Meeting

Retrieved on: 
Thursday, November 16, 2023
CCH, Post hoc analysis, User experience, Randomness, PD, Endo International, Collagenase clostridium histolyticum, Data analysis, Peyronie's disease, Control, Penile pain, Patient, OTC, Prior, Entamoeba histolytica, Pharmaceutical industry

DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.

Key Points: 
  • DUBLIN, Nov. 16, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that five new presentations related to Peyronie's disease, or PD, and XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) will be shared during the Sexual Medicine Society of North America (SMSNA) annual meeting, taking place November 16-19 in San Diego.
  • "The relatively common condition of Peyronie's disease—estimated to affect 1 in 10 men in the U.S.—remains under-studied and is often misunderstood," said Dr. Jesse Mills, urologist and presenter of the data analysis poster.
  • "Efforts like the post hoc analysis of XIAFLEX® Phase 3 data and the new landmark registry aim to advance medical knowledge of PD and support patient outcomes."
  • The five new Endo-sponsored and Endo-supported presentations are below:
    Peyronie's Disease Patients with Penile Pain at Baseline Treated with Collagenase Clostridium Histolyticum: A Post Hoc Analysis
    Outcomes of Collagenase Clostridium Histolyticum in Men with Ventral Curvatures: An Updated Series
    Efficacy of a Novel Collagenase Clostridium Histolyticum Protocol for Peyronie's Disease Among Prior Non-responders: A Randomized, Controlled, Single-Blinded Study
    Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 1 Year Outcomes