Teva gains final US approval for generic Aciphex
The US Food and Drug Administration has granted final approval for Israeli firm Teva Pharmaceutical Industries' Abbreviated New Drug Application for rabeprazole sodium delayed-release tablets, 20mg.
Teva's rabeprazole product is the AB-rated generic equivalent of Eisai's acid pump inhibitor Aciphex, which had annual sales of approximately $1.3 billion, based on IMS Health sales data.
As one of the first companies to file an ANDA containing a paragraph IV certification for this product, Teva says it has been awarded a 180-day period of marketing exclusivity.
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