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Eurand's Zentase Effective in Treating Exocrine Pancreatic,Insufficiency, Studies Show

.S. Federal Food, Drug and Cosmetic Act in 1938 and consequently none of the currently available products are marketed under a NDA approved by the FDA. In April, 2004, the FDA mandated that all manufacturers of EPI drug products file a NDA and receive approval for their products by April 2008 or be subject to regulatory action.

One of the FDA requirements to submit an NDA for a PEP is the elimination of product overfill allowed under current guidelines. Currently, individual enzyme doses can be overfilled up to 165 percent of label claim(3) to compensate for the breakdown of enzymes over time and to ensure that each capsule contains at least 90 percent of the label claim at the end of the product's shelf life. As a result, patients taking PEPs may be unknowingly over or under treating their disease by using a product with variable potency. This variability can put patients at risk for colonic strictures with overtreatment or malnutrition with undertreatment.

As a highly-stable product, Zentase does not require overfill. It will be filled at 100 percent of label claim, with a minimum of 2-years shelf life, to ensure consistent dosage and maintain treatment levels over time.

About Eurand

Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2000 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, customized release, taste-making/fast-dissolving formulations and drug conjugation.

Eurand is a global company with facilities in the USA and Europe. For more information, visit Eurand's website at www.eurand.com.

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