FDA Actions in Brief June 2012

July 1, 2012

Recent FDA Approvals (through June 2012) related to (GlaxoSmithKline, XenoPort, Roche)

A new indication for gabapentin enacarbil (Horizant, GlaxoSmithKline and XenoPort) extended-release tablets was approved for the management of postherpetic neuralgia in adults.

Pertuzumab (Perjeta, Roche) in combination with Herceptin (trastuzumab) and docetaxel chemotherapy was approved for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Meningococcal groups C and Y and haemophilus b tetanus toxoid conjugate vaccine (MenHibrix, GlaxoSmithKline) was approved for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. MenHibrix is approved for use in children aged 6 weeks through 18 months.