PHILADELPHIA, Dec. 26, 2008 Eurand N.V. a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced that it has been advised by GlaxoSmithKline that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter for the New Drug Application (NDA) for EUR-1048. EUR-1048 is an orally disintegrating tablet (ODT) formulation with an undisclosed active compound co-developed by Eurand and GSK.
GSK also has informed Eurand that it submitted its response to the Complete Response letter on December 24th and anticipates that the FDA will take up to 60 days to review the response and take action on the NDA.
Separately, the FDA also has advised GSK that the review of another collaborative product, EUR-1000, has been extended into 2009. EUR-1000 is an AB-rated generic equivalent to Inderal LA.
About Eurand
Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four partnered products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles, taste-masking/orally disintegrating tablet (ODT) formulations and drug conjugation.
Eurand is a global company with facilities in the U.S. and Europe. For more information, visit Eurand's website at http://www.eurand.com.
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