Following an initial FDA rejection in 2013, Otsuka Pharmaceutical Co. Ltd.'s tolvaptan, a drug for autosomal dominant polycystic kidney disease (ADPKD), has now won the agency's approval. The decision will give U.S. adults with the condition — the fourth leading cause of end-stage renal disease — access to a drug that has been available to those with ADPKD in Japan since 2014.