FDA actions in brief

July 4, 2013

FDA actions in brief

Telavancin (Vibativ, Theravance) was approved for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.  

A test that identifies the genotypeof hepatitis C virus (HCV) that a patient is carrying (The Abbott RealTime HCV Genotype II, Abbott Molecular) was approved. The test can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient’s blood plasma or serum, will aid healthcare professionals in determining the appropriate approach to treatment. 

Denosumab (Xgeva, Amgen) was approved for the treatment of adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually noncancerous tumor.

The use of levonorgestrel (Plan B One-Step, Teva Women’s Health) was approved as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013, order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter product without age or point of-sale restrictions.

Fluzone Quadrivalent vaccine (Sanofi Pasteur) supplemental biologics license application (sBLA) was approved. Fluzone Quadrivalent vaccine is the first and only 4-strain influenza vaccine option for patients as young as 6 months of age, as well as adolescents and adults.

New indication for lenalidomide (Revlimid, Celgene) was approved for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after 2 prior therapies, one of which included bortezomib.

Dabrafenib (Tafinlar, GlaxoSmithKline) and trametinib (Mekinist, GlaxoSmithKline) were approved for patients with advanced (metastatic) or unresectable melanoma. In addition, FDA also approved Tafinlar and Mekinist with a  genetic test (THxID-BRAF, bioMérieux S.A) that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene.

Neostigmine methylsulfate (Bloxiverz, Flamel Technologies) was approved for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.