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Food and Drug Administration / Hepatorenal syndrome / Syndromes / Pharmaceuticals policy / New Drug Application / Orphan drug / Terlipressin / Vasopressin / Medicine / Health / Pharmacology


FOR IMMEDIATE RELEASE FDA ACCEPTS FINAL SECTION OF NDA FILING FOR LUCASSIN® -- Priority Review Granted -Lebanon, NJ, and Clinton, NJ, June 12, 2009 – Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced today
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Document Date: 2011-06-28 11:52:57

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City

Madison / Seattle / Port Allen / /

Company

Orphan Therapeutics LLC / U.S. About Orphan Therapeutics LLC / Ikaria Holdings Inc. / /

Continent

Europe / /

Country

France / Japan / Canada / Australia / Mexico / Lebanon / Spain / South Korea / Ireland / /

Event

M&A / FDA Phase / /

IndustryTerm

manufacturing facility / treatment of hepatorenal syndrome / acute care products / treatment of hypoxic respiratory failure / manufacturing / /

MedicalCondition

late-stage liver cirrhosis / rare and serious diseases / kidney failure / renal failure / hypoxic respiratory failure / hepatorenal syndrome / /

Organization

U.S. Food and Drug Administration / FDA / /

Person

Clinton / /

Product

INOmax / LUCASSIN® / LUCASSIN® (terlipressin) / France / /

ProvinceOrState

Wisconsin / Louisiana / Washington / /

Region

Latin America / /

Technology

drug development / /

URL

www.ikaria.com / /

SocialTag