Kadmon reports FDA approval of Clovique generic product
Kadmon Holdings announced that the U.S. FDA has approved CLOVIQUE, a room-temperature stable, branded generic product. Trientine hydrochloride is used for the treatment of Wilson's disease in patients who are intolerant of penicillamine. "CLOVIQUE is an innovative treatment option that can be stored at room temperature, which is an added convenience for Wilson's disease patients," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We are pleased to offer CLOVIQUE to patients in need as part of our goal to develop novel therapies for chronic, rare diseases." Kadmon has immediately commenced commercialization activities for CLOVIQUE through Kadmon Pharmaceuticals, its wholly-owned commercial operation. In September 2019, the FDA approved Kadmon's generic Trientine Hydrochloride Capsules USP, 250 mg, available in 100-count bottles. The FDA had determined Kadmon's Trientine Hydrochloride Capsules to be bioequivalent and therapeutically equivalent to the reference listed drug, Syprine Capsules, 250 mg.