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Jul30
NDA of UCB, Inc.’s Xyzal®, Submitted to the USFDA

Xyzal® (levocetirizine dihydrochloride) is UCB, Inc. (Public, EBR: UCB)’s new prescription antihistamine for treatment of allergy symptoms, by which the company has recently submitted USFDA New Drug Application (NDA) of.

Xyzal®, while already available in many countries around the world, will offer U.S. physicians a new option to control allergy symptoms in affected patients, once approved.

"The NDA submission for Xyzal® is an alternative for U.S. physicians seeking an effective prescription treatment for patients that do not experience relief with existing medicines," said Roch Doliveux, CEO and chairman of UCB's Executive Committee.

"UCB is committed to helping meet unmet medical needs for patients with allergy symptoms that negatively impact their quality of life."

Xyzal® will be a once-daily antihistamine for which UCB has requested for the following indications: Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis, and Chronic Idiopathic Urticaria.

Read more at PR Newswire.

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» sanofi-ventis' Xyzal Tablets Get FDA Approvala from PharmaGazette
sanofi-aventis (EPA:SAN) and UBC announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/ml oral solution.Xyzal is an oral antihistamine, available only by pr... [Read More]

» sanofi-aventis' Xyzal Tablets Get FDA Approval from PharmaGazette
sanofi-aventis (EPA:SAN) and UBC announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/ml oral solution.Xyzal is an oral antihistamine, available only by pr... [Read More]

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« Dainippon Sumitomo Pharma Partners With Bristol-Myers K.K. On Anti-Hypertension And Hepatocellular Cancer Drugs | Main | USFDA Approved sNDA for Novartis Pharma Corp.’s Antiviral Agent Famvir® »

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