News
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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