FDA update on brand drugs for February 18, 2010

[chantell.reagan]

Expanded indications/labeling changes:

Benicar (olmesartan) by Daiichi Sankyo
Expanded indication: treatment of hypertension in pediatric patients 6 to 16 years of age

•Link to FDA letter
•Link to prescribing information

New dosage forms:

Norvir (ritonavir) heat-resistant 100mg tablet by Abbott
Indication: treatment of HIV-1 infection (does not require refrigeration)

•Link to Abbott press release 2/10
•Link to prescribing information

Safety issues:

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp
Safety issue: FDA is requiring all ESAs to be prescribed and used under a risk evaluation and mitigation strategy (REMS), to ensure the safe use of these drugs; patients are required to receive a medication guide, while healthcare professionals who prescribe ESAs to patients with cancer must complete a training

•Link to FDA safety communication 2/10

Sources:

U.S. Food and Drug Administration. Drugs@FDA. Available at: Drugs@FDA
U.S. Food and Drug Administration. Center for Biologics Evaluation and Research. Available at: CBER