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.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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