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Teva Pharm announces approval of Rabeprazole Sodium Delayed-Release Tablets

Thu Feb 22, 2007 4:48am EST
Co announces that the FDA has granted final approval for the Company's Abbreviated New Drug Application for Rabeprazole Sodium Delayed-Release Tablets, 20 mg. TEVA's Rabeprazole Sodium Delayed-Release Tablets are the AB-rated generic equivalent of Eisai's acid pump inhibitor Aciphex Tablets. The brand product had annual sales of ~$1.3 bln, based on IMS sales data. As one of the first companies to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.



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