FDA Accepts Generic Dexilant Application

2 March 2011 (Last Updated March 2nd, 2011 18:30)

Handa Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its abbreviated new drug application for Dexlansoprazole delayed-release capsules. According to Handa, Dexlansoprazole delayed-release is the generic version of Takeda’s popular Dexilant,

Handa Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted its abbreviated new drug application for Dexlansoprazole delayed-release capsules.

According to Handa, 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.

The FDA will now review the drug in its 60mg dosage.

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