FDA Actions in Brief May 2011 (Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant)

May 1, 2011

Recent FDA Approvals (through April 2011) related to Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant

Tocilizumab (Actemra, Genentech) given alone or in combination with methotrexate, was approved for the treatment of active systemic juvenile idiopathic arthritis in children aged 2 years and older.

Meningococcal conjugate vaccine (Menactra, Sanofi Pasteur), (meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), was approved to expand the indication to include a 2-dose schedule for infants and children aged 9 months through 23 months of age. This is the first US approval of a meningococcal vaccine for this age group.

Abiraterone acetate (Zytiga, Centocor Ortho Biotech) in combination with prednisone was approved to treat patients with metastatic castration-resistant prostate cancer who have received prior docetaxel.

Paliperidone (Invega, Janssen Division of Ortho-McNeil-Janseen Pharmaceuticals) extended-release tablets were approved for the treatment of schizophrenia in adolescents aged 12 to 17 years old.

Vandetanib (AstraZeneca) was approved for the treatment of symptomatic or progressive medullary thyroid cancer in patients with non-operable locally advanced or metastatic disease.

Nevirapine (Viramune XR, Boehringer Ingelheim) single-pill, once-daily, extended-release antiretroviral for use in combination with other antiretroviral drugs was approved for HIV-1 adult patients.

Gabapentin enacarbil (Horizant, GlaxoSmithKline and XenoPort) extended-release tablets were approved for the treatment of moderate-to-severe primary restless legs syndrome in adults.