Eisai Inc. announced today that the company has decided to discontinue global development of rabeprazole sodium extended-release capsules, 50 mg.
On February 1, 2011, Eisai received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application of rabeprazole sodium extended-release capsules, 50 mg. (U.S. brand name: Aciphex(R)). After full consideration of the discussion with the FDA regarding the CRL, it was determined that an additional study would be required to support approval. Upon further review, Eisai has decided to discontinue the global development of the product.