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S MLT A U.S. New Drug Application NDA for RHB-103 is currently being reviewed by the FDA with a PDUFA goal date of February 3 2014 TEL-AVIV Israel Nov. 18 2013 GLOBE NEWSWIRE -- RedHill Biopharma Ltd. S MLT the reference drug available in the U.S. In March 2013 following the successful bioequivalence study RedHill submitted to the FDA a New Drug Application NDA seeking marketing approval of RHB-103. We are encouraged by the positive feedback we received from the German BfArM said Dr. Reza...
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