FDA finally approves Plan B—but with restrictions
نویسندگان
چکیده
منابع مشابه
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...
متن کاملFDA 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...
متن کاملFDA 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...
متن کاملFDA 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 ...
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T hrough its Priority Review mechanism, the U.S. Food and Drug Administration (FDA) recently approved 2 radiopharmaceutical products for use as diagnostic PET agents. The first, approved on May 27, was Axumin (18F-fluciclovine) injection, indicated for use in PET imaging to identify suspected sites of prostate cancer recurrence in men with elevated levels of prostate-specific antigen (PSA) foll...
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ژورنال
عنوان ژورنال: BMJ
سال: 2006
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.333.7566.461