FDA tentatively OKs Intellipharmaceutics' generic Seroquel XR; shares up 19%

|By:, SA News Editor

The FDA grants tentative approval for Intellipharmaceutics' (IPCI +18.5%) generic version of AstraZeneca's (AZN -0.6%) Seroquel XR (quetiapine fumarate), an oral antipsychotic medicine indicated for the treatment of schizophrenia and manic/mixed episodes associated with bipolar disorder.

The approval is tentative because the company cannot launch the product until November 1 pursuant to a July 2012 settlement agreement with AstraZeneca. Also, there are two other companies with first-to-file status that may launch their versions on the same date. There is a 180-day exclusivity period related to first-to-file so Intellipharmaceutics' launch may be delayed until after this period.

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