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.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
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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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FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
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