Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has received a tentative approval to market generic Seroquel. Teva and Seroquel patent holder AstraZeneca have already been to court in the battle over the drug, and in July a New Jersey court upheld AstraZeneca's patent.
Teva announced US Food and Drug Administration (FDA) has granted tentative approval for an abbreviated new drug application (ANDA) to market its generic version of Seroquel (Quetiapine Fumarate) tablets in various dosages.
. Seroquel is prescribed to treat bipolar disorder and schizophrenia .The brand product had annual sales of approximately $3.8 billion in the United States for the twelve months that ended September 30, 2008, based on IMS sales data.
Final approval of the product is expected upon resolution of patent litigation.
Shares in Teva rose 0.4% on Nasdaq yesterday to close at $41.99, giving a market cap of $32.67 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on December 24, 2008
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