Ranbaxy to launch generic co-amoxyclav

By siliconindia   |   Tuesday, 10 December 2002, 20:30 IST
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BANGALORE: Ranbaxy Laboratories will launch its generic co-amoxyclav in January 2003 in the US market, the company said in a release to the BSE today. Ranbaxy had earlier received final approval from the US Food and Drug Administration to manufacture and market Amoxicillin and Clavulanate Potassium tablets. Based on bio-equivalent studies, the formulation has been deemed to be bio-equivalent and therefore, therapeutically equivalent to the listed drug (Augmentin® tablets of Glaxo SmithKline), the release said. Amoxicillin/Clavulanate potassium tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following condition: lower respiratory tract infections, otitis media, sinusitis, skin and skin structure infections and urinary tract infections. While Amoxicillin/Clavulanate potassium tablets are indicated only for the conditions previously listed, infections caused by Ampicillin susceptible organisms are also amenable to Amoxicillin/Clavulanate potassium tablets treatment due to its amoxicillin content. Therefore, mixed infections caused by Ampicillin-susceptible organisms and Beta-lactamase producing organisms susceptible to Amoxicillin/Clavulanate potassium tablets should not require the addition of another antibiotic, the release added.