FDA accepts Handa's generic DEXILANT ANDA for review

Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has been accepted for review by the U.S. Food and Drug Administration ("FDA"). Based upon available information, Handa believes that it is the first applicant to file an ANDA for DEXILANT® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Should its ANDA for Dexlansoprazole Delayed Release Capsules, 60 mg, be approved by the FDA, Handa believes that the product may be entitled to 180 days of generic market exclusivity.

According to IMS Health, annual sales of DEXILANT® Delayed Release Capsules, 60 mg, in the U.S. were about $300 million for the twelve months ended December 31, 2010.