FDA tentatively approves generic drug for schizophrenia, bipolar disorder

Intellipharmaceutics International earned tentative approval from the Food and Drug Administration for its quetiapine fumarate tablets.

The drug, intended to treat schizophrenia and bipolar disorder, is a generic version of London-based AstraZeneca's Seroquel tablets.

Intellipharmaceuticals can launch its generic version of Seroquel Nov. 1, as decided by a 2012 settlement between the Toronto-based drugmaker and AstraZeneca.

Once they hit the market, the quetiapine fumarate tablets could affect AstraZeneca's stake in the epilepsy drug market. Seroquel earned about $1.2 billion in U.S. sales for the 12 months ending in August 2016, according to Symphony Health Solutions.

 

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