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Ranbaxy gets US nod for Augmentin syrup version

Our Bureau

NEW DELHI, March 20

JUST two months after Ranbaxy's US-launch of the generic version of Augmentin in a tablet form - Ranbaxy today announced that it had received the green signal from US regulatory authorities to launch the bio-equivalent of Augmentin's oral suspension or a dry syrup dosage.

Augmentin is the blockbuster antibiotic from the GlaxoSmithKline (GSK) stable and the drug has been facing an onslaught from generic versions, as its patent expired in late December 2002.

The generic versions of the different forms of Augmentin are being rolled-out in the US market, even as GSK goes the whole hog in retaining its exclusivity on Augmentin, on the grounds that its patents are valid in the US till 2017.

But even as the patent-infringement suits filed by GSK in the US, against copy-cat versions of its Augmentin, take their own course - Ranbaxy Laboratories Ltd today announced that it had been granted the approval by the US Food and Drug Administration to market Amoxicillin and Clavulanate Potassium for Oral Suspension.

According to the company's communiqué, Ranbaxy's formulations were found to be bioequivalent and hence therapeutically equivalent to Augmentin's oral suspension, reported to be for paediatric use also.

Amoxicillin and Clavulanate Potassium for Oral Suspension are indicated to treat infections in the lower respiratory tract, skin and urinary tract infections.

GSK's Augmentin is said to have a combined sales of $1.2 billion with total sales of $272.5 million in the suspension market

Information was not available, however, on when Ranbaxy intends to launch the suspension version of Augmentin in the US market.

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