FDA actions in brief

ACTIONS IN BRIEF

Afatinib (Gilotrif, Boehringer Ingelheim) was approved for patients with late-stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

Two new indications were approved for the use lurasidone HCl (Latuda, Sunovion and Dainippon Sumitomo Pharma) as 1) monotherapy and 2) adjunctive therapy with either lithium or valproate, both to treat adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression).

Expanded indication for rivastigmine transdermal system (Exelon Patch, Novartis) 13.3 mg/24h to include the treatment of people with severe Alzheimer’s disease.

Buprenorphine/naloxone (Zubsolv, Orexo) sublingual tablet was approved for use as maintenance treatment for people suffering from opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support. 

A new drug application for neostigmine methylsulfate (Bloxiverz, Flamel Technologies) was approved for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

Coagulation Factor IX (Recombinant) (Rixubis, Baxter International) was approved for routine prophylactic treatment, control of bleeding episodes, and perioperative management in adults with hemophilia B. 

Low-dose paroxetine capsules (Brisdelle, Noven Pharmaceuticals), 7.5 mg/day, was approved for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, also referred to as hot flashes and night sweats.