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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