FDA's Drug Approval Down In 2010(AMGN, DNDN, WPI, GSK)

The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry has not yet escaped its drought in recent years, according to The Wall Street Journal. The trend for 2010 regulators within the FDA stepped up their cynicism of safety issues in drugs for obesity, diabetes, and other conditions. According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007. The number of applications received and final approval figures by the agency in 2010 will not be received until next month. The approval figures do not include dozens of approvals granted for new formulations or new uses of existing drugs. Nevertheless, Amgen AMGN won approval for Prolia, a drug that is injected bi-annually to treat osteoporosis in postmenopausal women. Roche Holding AG's biotechnology unit, Genentech, won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis. In August, the FDA approved a longer-lasting emergency contraceptive that's designed to block pregnancy up to five days after sex. The product was developed by HRA Pharma, a company in Paris, and was introduced in the U.S. earlier this month by Watson Pharmaceuticals WPI. In April, Dendreon DNDN won approval for its prostate cancer therapy Provenge, which had previously been rejected by the agency. Provenge is designed to use a patient's own cells to stimulate the body's immune system to fight the cancer and may be the first in a new class of cancer-fighting drugs. The FDA closed the books on one of the highest profile drug-safety matters in recent years by sharply curtailing the use of GlaxoSmithKline's GSK diabetes drug Avandia in September after it was linked to increased risks of heart attacks.