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Ranbaxy's Augmentin gets US clearance

Our Bureau

New Delhi , Dec. 8

RANBAXY Laboratories Ltd (RLL) has received the final approval from the US regulatory authorities to manufacture and market the bio-equivalent version of the antibiotic Augmentin in its chewable form.

GlaxoSmithKline is the original patent holder for Augmentin.

According to a Ranbaxy communiqué, issued here on Monday, the Division of Bioequivalence has determined Ranbaxy's Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) in the strengths 200 mg/28.5 mg (base) and 400 mg/57 mg (base), to be bioequivalent and, therefore, therapeutically equivalent to the listed drug Augmentin{logicalnotshy} chewable tablets, 200 mg and Augmentin chewable tablets, 400 mg, respectively of GlaxoSmithKline.

Total market sales of all forms of Amoxicillin and Clavulanate Potassium chewable tablets are estimated to be around $31.4 million.

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