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DKS
Friday, 26 December 2008
Quetiapine Fumarate: Teva got tentative approval
Teva Pharma announced today that the United States Food and Drug Administration (USFDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of AstraZeneca's antipsychotic agent Seroquel® (Quetiapine Fumarate) Tablets, Eq. 25 mg base, 50 mg base, 100 mg base, 150 mg base, 200 mg base, 300 mg base and 400 mg base.
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.
It is pertinent to mention here that generic players like Teva and Sandoz tried to invalidate inoovator Astra’s Orange Book listed product patent US4879288 (Expiry: September 26, 2011) in New Jersey District court. However, court upheld the validity of said patent. Teva can launch its generic version of Quetiapine after September 26, 2011.
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