Jun 30, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Janssen's antipsychotic agent Risperdal(R) (Risperidone) Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. Shipment of these products has commenced.
As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
The details can be read here.
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