FDA update for brand drugs for June 3, 2010

[chantell.reagan]

Prolia (denosumab) by Amgen
Approval: treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
•Of note: Prolia is given every 6 mo (60 mg subcutaneous injection administered by a health care professional)

•Link to Amgen press release 6/10
•Link to prescribing information

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