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Article Excerpt
The consumer advocacy group Public Citizen has asked a federal district court to force the FDA to act on the group's petition asking the agency to require a "black-box" warning on the product labels of a certain category of antibiotic drugs marketed in the United States. (Public Citizen, Inc. v. FDA, No. 1:08-CV-00005 (D.D.C. filed Jan. 3, 2008).)
Citing the risk of serious tendon injury associated with Cipro (ciprofloxacin), Levaquin (levofloxacin), and other fluoroquinolone antibiotics, Public Citizen filed its labeling request with the FDA on August 29, 2006. The petition asked the agency to require manufacturers to add a black-box warning, send a "Dear Doctor" letter to physicians about the...
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