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

January 1, 2012

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.