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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
Levofloxacin had reached blockbuster status by this time; combined worldwide sales of levofloxacin and ofloxacin for J&J alone were US$1.6 billion in 2009. [ 67 ] The term of the levofloxacin United States patent was extended by the U.S. Patent and Trademark Office 810 days under the provisions of the Hatch Waxman Amendment so that the patent ...
An auxiliary label (also called cautionary and advisory label or prescription drug warning label) is a label added on to a dispensed medication package by a pharmacist in addition to the usual prescription label. These labels are intended to provide supplementary information regarding the safe administration, use, and storage of the medication. [1]
Old Dominion Freight Line, Inc. (ODFL) is an American regional, inter-regional and national less than truckload shipping (LTL) company. In addition to its core LTL services, the company offers expedited, logistics and household moving services. [4] [5]
Quinolone antibiotics constitute a large group of broad-spectrum bacteriocidals that share a bicyclic core structure related to the substance 4-quinolone. [1] They are used in human and veterinary medicine to treat bacterial infections, as well as in animal husbandry, specifically poultry production.
This would indicate a small degree of biliary excretion, as well. Plasma elimination half-life is around 4 to 5 hours in patients and 6.4 to 7.4 hours in elderly patients. [9] Ofloxacin is a racemic mixture, which consists of 50% levofloxacin (the biologically active component) and 50% of its “mirror image” or enantiomer dextrofloxacin. [52]
Included were the popular drugs Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin) and Floxin . [19] On July 1, 2009, the FDA required Chantix (varenicline) to carry a boxed warning due to public reports of side effects including depression, suicidal thoughts, and suicidal actions.