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FDA Actions in Brief May 2011 (Actemra, Menactra, Zytiga, Rituxan, Invega, Vandetanib, Viramune XR, Horizant)
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.
FDA Sets Date of Advisory Committee Meeting for Donanemab in Alzheimer’s Disease
May 7th 2024The Peripheral and Central Nervous System Drugs Advisory Committee will meet on Monday, June 10, 2024, to discuss the phase 3 trial of Lilly’s donanemab to treat patients with early symptomatic Alzheimer’s disease.
FDA Approves Xolremdi for Ultra Rare Immune Disorder
April 29th 2024Xolremdi is the first therapy for WHIM syndrome, which can cause recurrent lung infections and papillomavirus-related warts. It’s available in two doses: 400 mg for an annual cost of $496,400 and 300 mg for an annual cost of $372,300.
