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news.Handa Pharmaceuticals has confirmed that its abbreviated new drug application for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca's Seroquel XR, has been accepted for filing by the FDA.
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Based upon available information, Handa believes that it is the first applicant to file an abbreviated new drug application (ANDA) for Seroquel XR containing a paragraph IV certification, under the provisions of the Hatch- Waxman Act.
Should its ANDA be approved by the FDA, Handa believes that its product will be entitled to 180 days of generic market exclusivity.