Intellipharmaceutics International Inc. announced the filing of an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic 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 US were approximately $823 million in 2010.
“The filing of a generic version of Seroquel XR is one of the company's performance milestones for 2011 and another important addition to our product portfolio filed for approval with the FDA, which includes generics of Focalin XR, Effexor XR, Protonix DR and Glucophage XR,” commented Dr Isa Odidi, CEO of Intellipharmaceutics. “These filings not only provide further validation of our Hypermatrix technology, they clearly demonstrate the flexibility of our technology to efficiently and effectively match a number of drug delivery profiles.”
Intellipharmaceutics now has five ANDAs awaiting FDA approval with reported sales for branded and generic versions of these products being approximately $8 billion in 2010. The company develops both ANDA product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway.
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The company's patented Hypermatrix technology is a unique and validated multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals.