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www.fdanews.com/articles/91853-mylan-wins-approval-for-first-generic-cipro-xr

Mylan Wins Approval for First Generic Cipro XR

March 27, 2007

Mylan Laboratories has announced the approval and launch of its latest first-to-market generic product, ciprofloxacin extended-release tablets in 500- and 1,000-mg strengths.

The company began shipping the product immediately upon approval last week.

Mylan's product is the generic version of Bayer Pharmaceuticals' Cipro XR (ciprofloxacin) tablets, which had U.S. sales of approximately $45 million for the 500- and 1,000-mg strengths in 2006, according to IMS Health data cited by Mylan.

Cipro is an antibiotic an antibiotic in the quinolone class indicated for treating uncomplicated urinary tract infections.

Mylan also recently announced the launch of a generic version of Pfizer's hypertension drug Norvasc (amlodipine besylate) with 180 days of market exclusivity triggered by the company's first-to-file status.