Intellipharmaceutics announces FDA acceptance to file ANDA for Protonix generic version

Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) today announced that the Food and Drug Administration (FDA) has accepted for filing its abbreviated new drug application (ANDA) for a generic version of Protonix^® (delayed release pantoprazole sodium). Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome. Sales of pantoprazole sodium delayed-release tablets in the United States were approximately $1.8 billion in 2009. 

"FDA acceptance of filing of our ANDA for generic Protonix is a key milestone and is representative of the impressive progress we continue to make at Intellipharmaceutics," commented Dr. Isa Odidi, CEO and Co-Chief Scientific Officer of Intellipharmaceutics. "Our generic products under review with the FDA now include generic versions of Protonix DR, Effexor XR, and Focalin XR, and when taken together with our abuse-deterrent Rexista oxycodone program, I believe our Company is very well positioned to realize significant value for our shareholders."

Intellipharmaceutics endeavors to develop its pipeline products to an advanced stage after which it seeks commercialization and distribution partners for its products. No assurance can be given as to when or if the FDA will approve the Company's applications for its products.