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FDA approves generic version of Abbott drug

The US Food and Drug Administration has approved the first generic version of Abbott Laboratories drug Depakote
The US Food and Drug Administration (FDA) has approved the first generic version of Abbott Laboratories drug Depakote, which is used in the US for the treatment of seizures, bipolar disorder and migraine headaches.

A number of generic manufacturers have now been given approval by the FDA to market the generic medicine, divalproex sodium, which will carry the same safety warnings as the branded Abbott product. The companies include Sun Pharmaceutical Industries, Genpharm, Nu-Pharm, Teva pharmaceuticals, Dr Reddy's Laboratories, Sandoz, Upsher-Smith Laboratories, and Lupin Limited.

Depakote is Abbottís second highest earning pharmaceutical product and with sales of $387m in the US and $27m in the rest of the world in the second quarter of 2008, the influx of generics on the market could have a significant impact on future sales.

"We have fully accounted for generic competition to Depakote in our financial forecast," said Scott Stoffel, director of external communications at Abbottís office of corporate public affairs. "Our strategic approach of investing in a diverse portfolio of innovation-driven products in high-growth markets has not only delivered strong financial performance, but has also positioned the company well to serve investors and patients in the future."

After reporting earnings per share (EPS) of $0.84 for the first half of 2008, beating the Thomson First Call mean of $0.79 by 5 cents, Abbott raised its EPS guidance range from $3.20-$3.25 to $3.24-$3.28 for the full year. In addition, the company raised sales guidance for its leading drug product Humira to $4.3bn for 2008.

30th July 2008

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