TEVA GETS TENTATIVE APPROVAL FOR GENERIC PROTONIX

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Israel's Teva Pharmaceutical reported that the U.S. FDA has granted tentative approval for the company's abbreviated new drug application (ANDA) to market its generic version of Wyeth's Protonix (pantoprazole sodium) delayed release (DR) tablets in 20 mg and 40 mg. Protonix DR tablets are indicated for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions.

The drug's full approval is contingent upon either a favorable decision in a patent suit brought against Teva by Wyeth -- currently pending in the U.S. District Court of the District of New Jersey -- or on the expiration of the mandatory stay of approval in August 2007.