Generic Antipsychotic Receives Tentative Approval by FDA

Intellipharmaceutics announced they have received tentative approval from the Food and Drug Administration (FDA) for their Abbreviated New Drug Application (ANDA) for the generic equivalent to the antipsychotic Seroquel XR (quetiapine fumarate extended-release; Astra Zeneca).

The strengths of the tablets in the ANDA are the corresponding equivalent of current marketed Seroquel XR strengths; 50, 150, 200, 300 and 400mg. In accordance with a settlement agreement between Intellipharmaceuticals and AstraZeneca on July 30, 2012, and subject to final approval, the company is permitted to launch on November 1, 2016. 

However, any approval is subject to a 180 day exclusivity period relating to a prior generic filer of Seroquel XR, and to the companies knowledge two companies currently hold first-to-file status. Considering this, the company’s intent is to launch after final approval and when the exclusivity period for the current first-to-file company expires.

Seroquel XR, and the drug active quetiapine fumarate, are indicated for use in the treatment of schizophrenia and bipolar disorder. There are currently no generics of Seroquel XR available in the US. “We are thrilled the FDA has granted tentative approval of our generic version of Seroquel XR, which should further demonstrate our core drug development competency in controlled-release delivery technologies,” said Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics.

For more information visit Intellipharmaceutics.com.