IPCI: Now has five ANDAs awaiting FDA approval Print E-mail
By Staff and Wire Reports   
Monday, 04 April 2011 06:10
Intellipharmaceutics (Nasdaq:IPCI), one of the biotech companies whose future as both a near and long-term and investment we've been covering and following closely, today announced the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for a generic of Seroquel XR®.

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Seroquel XR® is an oral psychotropic agent indicated for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. Sales of Seroquel XR® (quetiapine fumarate extended-release tablets) in the U.S. were approximately $823 million in 2010.

We expect the shares of this very low-float stock will move on this news alone, much less with news about any of the five ANDAs awaiting FDA approval. The reported sales for branded and generic versions of those pending approval products came in at approximately $8 billion in 2010. IPCI develops both ANDA product candidates and new drugs through the New Drug Application (NDA) 505(b)(2) regulatory pathway.

"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.




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