Intellipharmaceutics International Inc. announced the U.S. Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for a generic version of Seroquel XR (quetiapine fumarate extended-release tablets). Seroquel XR is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. Sales of Seroquel XR in the U.S. were approximately $823 million in 2010.
“We were very pleased with the FDA’s acceptance of our filing for a generic of Seroquel extended-release tablets,” commented Dr. Isa Odidi, CEO of Intellipharmaceutics. “I believe this speaks to the quality of our application and the work that is being performed at Intellipharmaceutics.”
Intellipharmaceutics has five ANDAs awaiting FDA approval. The company develops both ANDA product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway.
Date: May 3, 2011
Source: Intellipharmaceutics International Inc.
