Issue link: https://www.e-digitaleditions.com/i/819216
Tablets & Capsules May 2017 9 FDA approves first treatments for tardive dyskinesia, NSCLC SILVER SPRINGS, MD—The FDA approved Neurocrine Biosciences' Ingrezza (valbenazine), the first treat- ment for tardive dyskinesia, a neurolog- ical disorder. Adults with this condition experience repetitive involuntary movements. In other news, the Agency also approved AstraZeneca's Tagrisso (osimertinib) to treat patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation- positive non-small cell lung cancer (NSCLC) whose disease has pro- gressed after EGFR tyrosine kinase inhibitor therapy. The once-daily tablet treatment is the first medicine approved in the USA for NSCLC patients who have tested positive for the EGFR T790M mutation. Briefly noted… The FDA approved Tesaro's Zejula (niraparib) to treat adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in com- plete or partial response to platinum- based chemotherapy. The FDA approved Symproic (naldemedine), a once-daily tablet for treatment of opioid-induced con- stipation in adults with chronic non- cancer pain. It is manufactured by Shionagi and Purdue Pharma. The FDA approved Newron Pharmacetuicals' Xadago (safi- namide) as an add-on treatment for patients with Parkinson's disease who take levodopa/carbidopa and experi- ence "off" episodes. These are periods when the medication isn't working well and patients have tremors and difficulty walking.