Ranbaxy Gets Fda Nod For Anti-Infective

Ranbaxy Laboratories has received the final approval to manufacture and market cefpodoxime proxetil for oral suspension from the US Food and Drug Administration (USFDA).

The bio-equivalence division of FDA determined Ranbaxy's formulation of cefpodoxime proxetil to be bio-equivalent to Vantin, a similar listed drug of Pharmacia and Upjohn Co.

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.

According to IMS figures for December 2001, the sales for cefpodoxime proxetil suspension totalled $ 15.3 million and represented 37 per cent of the total market for cefpodoxime proxetil.

 

The drug is prescribed to patients with mild to moderate infections caused for susceptible strains of designated micro-organisms for conditions such as pharyngitis or tonsillitis, community-acquired pneumonia, acute bacterial exacerbation of chronic bronchitis, acute, uncomplicated urethral and cervical gonorrhea, acute, uncomplicated ano-rectal infections in women, uncomplicated skin and skin culture infections, acute maxillary sinusitis and uncomplicated urinary tract infections.

According to Ranbaxy, the product represents yet another addition to the expanding product portfolio of anti-infectives that comprise not only solid dosage forms but also a growing number of products in liquid versions and other value-added dosages. The drug will be made available in three sizes including 50, 75 and 100 ml bottles. It is anticipated that at the time of the launch, the product will be distributed broadly to all distribution points in the US, including wholesalers, pharmacies, hospitals and so on.