Teva gets tentative approval for generic Protonix DR
Israel's Teva Pharmaceutical Industries says that the US Food and Drug Administration has granted tentative approval for its Abbreviated New Drug Application to market its generic version of Wyeth's Protonix (pantoprazole sodium) Delayed Release tablets, 20mg and 40mg.
On final approval, Teva's pantoprazole sodium DR will be the AB-rated equivalent of Protonix DR Tablets, a product indicated for short-term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions.
Annual brand product sales in the USA were approximately $2.4 billion for the12 months ended December 2005.
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