After the close on Friday, Intellipharmaceutics International (IPCI) received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for quetiapine fumarate extended-release tablets in the 50,150, 200, 300 and 400 mg strengths. Shares were surging 16% in Monday’s pre-market.
This is a generic equivalent for the corresponding strengths of AstraZeneca’s (AZN) Seroquel XR.
Pursuant to a settlement agreement between Intellipharmaceutics and AstraZeneca dated July 30, 2012, Intellipharmaceutics is permitted to launch its generic versions of the 50, 150, 200, 300 and 400 mg strengths of generic Seroquel XR, on Nov 1, subject to FDA final approval of the company’s ANDA.
There are currently no generics of Seroquel XR available in the U.S. as the drug is still under AstraZeneca’s patent protection until November 1, 2017.