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8 Mar 2011

FDA Nods Generic Dexilant Application

The FDA has accepted the new drug application by Handa Pharmaceuticals for Dexlansoprazole delayed-release capsules.

Handa Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its abbreviated new drug application for Dexlansoprazole delayed-release capsules. The FDA will now review the drug in its 60mg dosage.


Dexlansoprazole delayed-release is the generic version of Takeda’s popular Dexilant, and is used as an oral treatment for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease.


Annual sales of Dexilant in the US reached approximately $300m in 2010.

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