FDA actions in brief
Briefs of FDA actions/approvals of drugs, doses, and indications
Key Points
Protein C concentrate (human) (Ceprotin, Baxter) was approved as replacement therapy in patients with life-threatening blood-clotting complications related to severe congenital Protein C deficiency.
H5N1 vaccine (Sanofi Pasteur) was approved for the prevention of H5N1 avian influenza.
FDA approved RhO(D) immune globulin intravenous (human) (Rhophylac, CSL Behring) for the treatment of immune thrombocytopenic purpura (ITP). This agent was previously approved for the prevention of hemolytic disease of the newborn and for the suppression of Rh isoimmunization in pregnancy and obstetric conditions and following an incompatible transfusion.
A new dose of risedronate (Actonel, Procter & Gamble/Sanofi-Aventis) was approved for the treatment and prevention of postmenopausal osteoporosis. The new dose will allow patients to take one 75-mg tablet daily on 2 consecutive days once per month.
A new 12.5-mg dose of risperidone (Risperdal Consta, Janssen) was approved for the treatment of schizophrenia within specific patient populations, including those with renal and hepatic impairment.
FDA has approved a new accelerated dosing schedule for hepatitis A (inactivated) and hepatitis B (recombinant) vaccine (Twinrix, GlaxoSmithKline). Three doses of the agent can now be administered within 3 weeks, followed by a booster dose at 12 months.
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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