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Bausch Health's DEXAVEN (Dexamethasone Phosphate) Receives New Indication In Poland To Treat Patients With SARS-CoV-2 (COVID-19)

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Bausch Health Companies (NYSE/TSX: BHC) announced a new indication for DEXAVEN (dexamethasone phosphate) solution for injection in Poland. This approval allows treatment for COVID-19 in adults and adolescents who require oxygen therapy. The corticosteroid DEXAVEN helps reduce inflammation. CEO Thomas J. Appio expressed satisfaction with this development as it provides additional treatment options for patients. However, it is important to note that dexamethasone products are not FDA-approved for COVID-19 treatments in the United States.

Positive
  • Approval of DEXAVEN for COVID-19 treatment in Poland enhances treatment options for patients.
  • Strengthens Bausch Health's product portfolio amid ongoing pandemic.
Negative
  • Dexamethasone products remain unapproved for COVID-19 by the FDA in the U.S., limiting market potential.
  • Risks associated with evolving COVID-19 pandemic may impact project development timelines and costs.

LAVAL, QC, Dec. 30, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), today announced that the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland has granted an additional new indication for DEXAVEN (dexamethasone phosphate) solution for injection, 4 mg/ml, for the treatment of COVID-19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who require oxygen therapy. DEXAVEN is a corticosteroid that reduces inflammation. 

"We're pleased that Poland's Office for Registration of Medicinal Products, Medical Devices and Biocidal Products has approved DEXAVEN for the treatment of symptoms due to COVID-19, because now patients in Poland have another treatment option to fight this virus," said Thomas J. Appio, president, Bausch + Lomb/International, Bausch Health. "Bausch Health continues to evaluate our health care products and medicines around the world to determine if they may offer valuable treatment options for COVID-19, and we will continue to do what we can to assist in the global efforts to end the pandemic."

Dexamethasone-containing products in the United States are not approved as a treatment for COVID-19 by the U.S. Food and Drug Administration. Patients should only use these products in accordance with their approved label and the directions of their doctor.

About Bausch Health

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.

Forward-looking Statements

This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on Bausch Health, including but not limited to its project development timelines, and costs (which may increase). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

Investor Contact:

Media Contact:

Arthur Shannon

Lainie Keller

arthur.shannon@bauschhealth.com

lainie.keller@bauschhealth.com

(514) 856-3855

(908) 927-1198

(877) 281-6642 (toll free)


 

Bausch Health logo (PRNewsfoto/Bausch Health Companies Inc.)

 

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SOURCE Bausch Health Companies Inc.

FAQ

What new indication was granted to DEXAVEN by Bausch Health?

DEXAVEN received approval in Poland for the treatment of COVID-19 in patients needing oxygen therapy.

How does DEXAVEN work as a treatment for COVID-19?

DEXAVEN is a corticosteroid that reduces inflammation, which can be beneficial for COVID-19 patients.

Is DEXAVEN approved in the United States for COVID-19?

No, dexamethasone products are not FDA-approved for the treatment of COVID-19 in the U.S.

What is Bausch Health's stock symbol?

Bausch Health is listed under the stock symbol BHC.

What impact does the approval of DEXAVEN have on Bausch Health's business?

The approval enhances Bausch Health's product offerings, potentially improving market presence, but FDA restrictions in the U.S. pose challenges.

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