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Regulatory Bodies & Rulings
APL's Ciprofloxacin gets nod
Our Bureau
Hyderabad, June 6
Aurobindo Pharma Ltd (APL) has announced that the US Food and Drug Administration (US FDA) has approved its Ciprofloxacin tablets in strengths 250, 500 and 750mg. Ciprofloxacin is the generic international name for the synthetic microbicide manufactured and sold by Bayer Pharmaceutical under the brand names Cipro, Ciproxin and Ciprobay.
Ciprofloxacin is considered a yardstick with which the other quinolones efficacies are measured against. Ciprofloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria, according to a release from the Hyderabad-based pharma major. The product is used in lower respiratory infections (pneumonias), urinary tract infections, STDs, septicemias, Legionellosis and in some atypicals. APL has also said that the company regrets its earlier announcement of cefpodoxime proxetil approval, which was displayed by the FDA on their Web site. However, this product is still awaiting official approval.
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