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Ultra low-cost artificial leg developed
JERUSALEM, April 21 (UPI) -- Teva said Friday it has been tentatively approved to market a generic version of Wyeth's Protonix for reflux disease.
The Israel-based drug maker said the Food and Drug Administration has given tentative approval to its generic version of Wyeth's Protonix Sodium Delayed Release Tablets (pantoprazole sodium) in 20 mg and 40 mg strengths.
The product is a generic equivalent of Protonix DR Tablets, indicated for the short-term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and to treat hypersecretory conditions.
Teva estimated 2005 U.S. sales of Protonix at about $2.4 billion.
The FDA's approval of the generic drug is conditioned on a favorable judgment in a patent suit related to the product now pending in a New Jersey district court or on expiration of the mandatory stay of approval in August 2007.
Teva noted that a trial date has not yet been set in the patent case, which was filed in May 2004.
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