FDA Actions in Brief October 2011 (Remicade, Prolia, haloperidol injection, Soliris)
Recent FDA Approvals (through September 2011) related to Remicade, Prolia, haloperidol injection, Soliris
Infliximab (Remicade, Janssen Biotech) was approved for the treatment of moderately to severely active ulcerative colitis in pediatric patients older than 6 years who have had an inadequate response to conventional therapy.
Two new indications for denosumab (Prolia, Amgen) were approved. Prolia has been approved as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer, and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer. Prolia is the first-and-only therapy approved by FDA for cancer treatment-induced bone loss in patients undergoing hormone ablation therapy.
Haloperidol injection USP (Sagent) antipsychotic in 5 mg per mL single-dose and 50 mg per 10 mL multi-dose, latex-free vials was approved for the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.
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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