FDA approval Floxin – Ofloxacin clinical trails
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FDA Approval for Floxin – Ofloxacin

The Food and Drugs Administration of the United States gave final approval to Ortho McNeil Pharmaceuticals for the manufacture and sale of Floxin on 28th December, 1990. Ofloxacin is sold under the brand name Floxin in the US and Tarivid in Europe and some countries in Asia. Floxin is a fluoroquinolone. In clinical trials, Ofloxacin has exhibited the side effects which are common to other fluoroquinolones. The FDA has approved the use of Ofloxacin for the treatment of gonorrhea.

The drug has also been approved by the FDA for use in the treatment of respiratory tract infections. Clinical trials have been conducted to test the effectiveness of the pill in the treatment of syphilis. But so far, the drug has not had any effect on the disease. So using the drug for treating syphilis is not approved by the FDA. The FDA has attached several warning labels to Ofloxacin.

The FDA has attached warning labels which warn potential users that Ofloxacin may cause Peripheral Neuropathy, heart problems, tendon damage, pseudo membranous colitis, muscle wasting and Steven Johnson Syndrome. Clinical studies have shown that ruptured tendons are more likely to occur if the patients are being treated with corticosteroids along with Ofloxacin. So the FDA advises against the use of corticosteroids when patients are being treated with Ofloxacin.

The FDA has advised against using the combination of corticosteroids and Ofloxacin in elderly patients as they are more at risk to rupture their tendons. The FDA has also approved the use of Ofloxacin for use in the treatment of anthrax. Ofloxacin may be used as an alternative to ciprofloxacin.
 

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