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Ranbaxy gets U.S. FDA nod for Proxetil

NEW DELHI JUNE 4. Ranbaxy Laboratories has received the final approval to manufacture and market Cefpodoxime Proxetil for oral suspension from the U.S. Food and Drug Adminstration (FDA).

Ranbaxy plans to introduce the product once the New Jersey Federal district court decides in its favour on the preliminary injunction motion filed by Pharmacia and Upjohn Co, a company release said today.

The FDA's bio-equivalence division determined Ranbaxy's formulation of Cefpodoxime Proxetil as the bio-equivalent of a similar listed drug of Pharmacia and Upjohn Co.

The drug is prescribed to patients with mild to moderate infections causing pharyngitis or tonsillitis, community acquired pneumonia, acute chronic bronchitis, acute, uncomplicated urethral and cervical gonorrhea. — PTI

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