Dr. Reddy' s gets US FDA approval for ciprofloxacin tablets
Dr. Reddy's Laboratories announced that the United States Food and Drug Administration (US FDA) has issued final approval for the company's Abbreviated New Drug Application for ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.
The company is eligible for 180-days of market exclusivity for the 100 mg strength.
Ciprofloxacin is the AB-rated generic equivalent of Bayer Corporation's Cipro. Cipro is a broad-spectrum antibiotic, approved for the treatment of several types of infection. As per IMS 2003, the product had annual US brand sales of approximately US $1 billion.