FDA approves drugs even when experts on its advisory panels raise safety questions

FDA Briefing Document May 4,2004 Oncologic Drugs Advisory Committee Safety Concerns Associated with Aranesp

FDA approves new drug to treat dementia.

Actavis and Adamas Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration has approved the New Drug Application for NamzaricTM for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Namzaric will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezi...

FDA approves regorafenib (Stivarga) for metastatic colorectal cancer.

“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives, and is the second drug approved for patients with colorectal cancer in the past 2 months,” said Richard Pazdur, MD, director of the office of hematology and oncology products in FDA’s Center for Drug Evaluation and Research, in a press release. In August, the FDA approved aflibercept (Zaltra...

FDA approves 11C-choline for PET in prostate cancer.

T he U.S. Food and Drug Administration (FDA) announced on September 12 approval of production and use of 11C-choline for PET imaging in recurrent prostate cancer. The Mayo Clinic PET Radiochemistry Facility (Rochester, MN) will be the first approved facility to produce the tracer injection. 11C-choline must be produced in a specialized facility and must be administered to patients shortly after...

FDA approves aflibercept (Zaltrap) for metastatic colorectal cancer.

“This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied ...