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.