Tablets & Capsules


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Tablets & Capsules April 2018 9 pharmaceutical manufacturing sys- tems that are expected to receive FDA approval and create new pro- duction capabilities. Briefly noted… The FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor for the treatment of postmenopausal women with hor- mone receptor-positive, human epi- dermal growth factor receptor 2-neg- ative advanced or metastatic breast cancer. The product is manufactured by Eli Lilly, Indianapolis, IN. Apadaz (benzhydrocodone and acetaminophen), manufactured by KemPharm, Coralville, IA, was approved by the FDA for the short- term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The FDA has also approved Symdeko (tezacaftor/ivacaftor and ivacaftor) manufactured by Vertex Pharmaceuticals, Boston, MA, to treat the underlying cause of cystic fibrosis in patients age 12 and older who have two copies of the F508del mutation in the cystic fibrosis trans- membrane conductance regulator gene or who have at least one muta- tion that is responsive to tezacaftor/ ivacaftor.

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