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FDA admits Sun's appeal

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US drugs regulator food and drug administration (FDA) has accepted a generic challenge by India’s Sun Pharmaceuticals Industries Ltd against Glivec, a controversial mega-earner cancer drug of Novartis AG, potentially weakening the Swiss drug maker’s petition against an Indian ruling denying the drug a patent.
The challenge in the US, if it invalidates Novartis’ patent, will not only significantly stre-ngthen the plea of local drug makers here, but also open up a huge generics market for them in the US for this drug, which, last year, grossed some $2.5 billion (Rs11,605 crore then), equivalent to more than one-10th of Novartis’ revenues.

The challenge in the US, if it invalidates Novartis’ patent, will not only significantly stre-ngthen the plea of local drug makers here, but also open up a huge generics market for them in the US for this drug, which, last year, grossed some $2.5 billion (Rs11,605 crore then), equivalent to more than one-10th of Novartis’ revenues.

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