FDA Updates from August 2019

We’re starting a new blog series to update you on recent FDA drug approvals, new indications, and other changes! You can find the recap or notable FDA drug changes for August 2019 below.

If we are missing information or you’d like more information about one of the noted changes, feel free to contact us.

ProductCompanyIndicationApprox Action DateResult
TuralioDaiichi SankyoTreatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. 8/2/19Approved
SirturoJanssenPediatric patients – those over the age of 12 and younger than 18 and weighing at least 66 lbs – with pulmonary multidrug-resistant tuberculosis, when an effective treatment regimen cannot otherwise be provided8/9/19Approved
PretomanidMylan/TB AllianceAdult patients with extensively drug-resistant, treatmetn-intolerant or nonresponsive multidrug-resistant pulmonary TB8/14/19Approved
KPI-121Kala PharmaceuticalsDry eye8/15/19Received CRL
WakixHarmony BiosciencesTreatment of excessive daytime sleepiness in adults with narcolepsy8/15/19Approved
RozlytrekGenentechTreatment of adult and pediatric patients with a variety of tumors that are positive for fusions in the neurotrophic tropomyosin receptor kinase gene. Also for the treatment of metastatic, ROS1-positive non-small cell lung cancer8/15/19Approved
HetliozVanda PharmaceuticalsJet lag disorder8/16/19Received CRL
InrebicCelgeneTreatment of adult patients with certain types of myelofibrosis8/16/19Approved
RinvoqAbbVieModerately to severely active rheumatoid arthritis patients who have had inadequate response or intolerance to methotrexate.8/16/19Approved
Barostim NeoCVRxReduced-ejection-fraction heart failure deemed unsuitable for other drug therapies8/16/19Approved
GolodirsenSarepta TherapeuticsDuchenne muscular dystrophy8/19/19Received CRL
XenletaNabrivaAn oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia8/19/19Apprvoed
TaltzEli LillyTreatment of adults with active ankylosing spondylitis8/26/19Approved
MyoblocUS WorldMedsTreatment of chronic sialorrhea in adults8/26/19Approved
NourianzKyowa KirinAdd-on treatment to levodopa/carbidopa in adults with Parkinson’s Disease experiencing ‘off’ episodes8/27/19Approved
RezistaIntellipharmaceuticsAbuse deterrent pain relief8/28/19Delayed (no decision yet)
NKTR-181NektarLow back pain8/29/19Delayed (no decision yet)
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