FDA Actions in Brief January 2012 (Antares, Isentress, REMS)
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.
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