Recent FDA Approvals (through December 2011) related to (Antares, Isentress, REMS)
Topical oxybutynin gel 3% (Antares, Watson Pharmaceuticals) product was approved for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Raltegravir (Isentress, Merck) was approved for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents aged 2 to 18 years. It was first approved in October 2007 for use in adults.
FDA has approved changes to the Risk Evaluation and Mitigation Strategies (REMS) for both romiplostim (Nplate, Amgen) and eltrombopag (Promacta, GlaxoSmithKline). Certain restrictive requirements of the REMS programs are no longer necessary to ensure that the benefits outweigh the risks. Healthcare professionals, hospitals, specialty care facilities, and patients are no longer required to be enrolled in the Nplate NEXUS Program or the Promacta CARES Program to prescribe, dispense, or receive these products. Healthcare professionals no longer have to complete periodic safety forms for patients receiving Nplate or Promacta. Pharmacies and pharmacists are no longer required to enroll in the Promacta CARES Program or verify prescriber and patient enrollment before dispensing Promacta. The modified REMS programs will include a communication plan that will inform healthcare professionals about the changes to the REMS.
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.
Listen
Iowa Expands PBM Legislation to Address Concerns of Independent Pharmacies
May 16th 2025A new law in Iowa, if signed by the governor, will mandate 100% pass-through of rebates, increased financial transparency, and a minimal payment for pharmacies. Critics say it will be the most costly mandate in the state’s history.
Read More
Is Arkansas’ New PBM Law the Right Path Forward for Reform? No One Knows Yet
May 9th 2025It could improve access to community pharmacies and lower prices. Or it will limit access to critical drugs and impact payers’ ability to contract for a broad range of services. Industry leaders are unsure about the impact of Arkansas’ law banning PBMs from owning pharmacies.
Read More