Le Lézard
Classified in: Health
Subject: FDA

Valeo Pharma Receives FDA Approval for Ethacrynate Sodium


MONTREAL, June 16, 2020 /CNW Telbec/ - Valeo Pharma Inc. (CSE: VPH) ("Valeo" or the "Company"), a Canadian specialty pharmaceutical company,  announced today that it has received approval for its Abbreviated New Drug Application ("ANDA") from the U.S. Food and Drug Administration ("FDA") for Ethacrynate Sodium 50 mg.   

"We are pleased to have received the FDA's authorization to begin commercializing Ethacrynate Sodium in the U.S.. This is the first regulatory approval we have received from the FDA and we expect sales of Ethacrynate Sodium to start this summer", said Steve Saviuk, Valeo's President and CEO. "In addition to Ethacrynate Sodium and our recent approval of Yondelis by Health Canada, we expect several additional Canadian regulatory approvals over the coming months".

Valeo's Ethacrynate Sodium will be distributed in the U.S. through its commercial partner. Valeo has been commercializing Ethacrynate Sodium in Canada since the third quarter of 2018 and owns the world wide rights to the product (ex-Italy). Valeo intends to pursue Ethacrynate Sodium out-licensing opportunities in other territories.  

About Ethacrynate Sodium

Ethacrynate Sodium injection belongs to a group of medicines called loop diuretics. Ethacrynate Sodium is administered to treat fluid retention (edema) and swelling that is caused by congestive heart failure, acute pulmonary oedema, renal oedema, hepatic cirrhosis with ascites or other medical conditions.

About Valeo Pharma

Valeo Pharma is a specialty pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Neurodegenerative Diseases, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit www.valeopharma.com and follow us on LinkedIn and Twitter.

Forward Looking Statements

This press release contains forward-looking statements about Valeo's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

SOURCE Valeo Pharma inc.


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