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news.Intellipharmaceutics International has filed an abbreviated new drug application (ANDA) with the FDA for a generic of Protonix (delayed release pantoprazole sodium).
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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.
Intellipharmaceutics said that Pantoprazole delayed-release tablets is the fourth ANDA product candidate that it 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.
Isa Odidi, CEO of Intellipharmaceutics, said: “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.”