FDA accepts Handa Pharma generic Dexilant ANDA PBR Staff Writer

Handa Pharmaceuticals said that the US Food and Drug Administration has accepted its Abbreviated new drug application (ANDA) for Dexlansoprazole delayed release capsules, 60mg for review.

The company claims that Dexlansoprazole delayed release capsules is the generic version of Takeda's Dexilant which is indicated as a once-daily oral treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).

Handa Pharmaceuticals is a specialty pharmaceutical company established in the San Francisco Bay area in November 2005.

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