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Teva receives FDA approval for generic Risperdal



By AP
30 June 2008 @ 05:48 pm EST

NEW YORK - Johnson & Johnson's blockbuster anti-psychotic drug Risperdal will face generic competition, as Teva Pharmaceutical Industries Ltd. on Monday became the first company to receive approval for a generic version.

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Israel-based Teva received Food and Drug Administration approval for a generic version of the blockbuster drug, used to treat schizophrenia and bipolar disorder, among other conditions. New Brunswick, N.J.-based Johnson & Johnson's Janssen unit had expected Risperdal's patent expiration this month, followed by tough generic competition over the key revenue driver.

The drug brought in $1.1 billion in sales during the first quarter. J&J plans to sell its own generic version of Risperdal through another unit, Patriot Pharmaceuticals, in order to compete with Teva and future competitors.

Israel-based Teva was the first company to ask for generic approval and has 180 days of marketing exclusivity. It will sell generic Risperdal in tablet doses ranging from 0.25 milligrams to 4 milligrams.

Shares of Teva rose 60 cents to close at $45.80, and shares of Johnson & Johnson added 77 cents to finish at $64.34.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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