WOODCLIFF LAKE, N.J. — The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.
The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the drug.
