The FDA claimed that longer-lasting injectable version of Eli Lilly's schizophrenia drug, Zyprexa, appears effective, though a small number of patients experienced excessive sleepiness.
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U.S. FDA warned that the review of Chantix tablets shows that the anti-smoking medication poses serious health risks and side effects.
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The U.S. Food and Drug Administration does not inspect U.S. plants that produce high-risk medical devices as often as it is necessary and checks few manufacturing sites overseas.
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On May 29, 2007 AstraZeneca, the maker of Prilosec (omeprazole) and Nexium (esomeprazole), sent FDA data from two long-term studies in patients with severe gastroesophageal reflux disease (GERD) that were being treated with either Prilosec or Nexium.
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The U.S. Food and Drug Administration has cleared for marketing the Binax NOW Malaria Test, the first authorized U.S. rapid test for malaria, a mosquito-borne disease caused by a parasite. The test is intended for laboratory use.
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The U.S. Food and Drug Administration announced on June 22nd a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements.
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The U.S. Food and Drug Administration approved on June 21st Lyrica (pregabalin), the first drug fibromyalgia treatment, a disorder characterized by pain, fatigue and sleep problems.
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Telik, Inc. (Nasdaq: TELK) announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the Investigational New Drug (IND) application for TELCYTA® (canfosfamide HCl).
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