Intellipharmaceutics International Inc. announced that is has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for a generic 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.
Pantoprazole delayed-release tablets is the fourth ANDA product candidate that Intellipharmaceutics has disclosed from its 15 product pipeline, which includes both ANDA product candidates and the development of new drugs through the S.505(b)(2) New Drug Application (NDA) regulatory pathway.
"I am extremely pleased with the progress we continue to make with the advancement of our product pipeline," commented Dr Isa Odidi, CEO of Intellipharmaceutics. "Protonix is the second ANDA we have filed with the FDA this year and, together with Focalin XR and Effexor XR, it represents another potential source of future revenue from our company's ANDA pipeline."
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel controlled and targeted release oral solid dosage drugs.