Teva Pharmaceutical Industries, a generic pharmaceutical company, has announced that the FDA has granted final approval for the company's abbreviated new drug application to market its generic version of Janssen's antipsychotic agent Risperdal oral solution, 1mg/ml. Shipment of this product has commenced.
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As the first company to file an abbreviated new drug application containing a paragraph IV certification for this product, Teva has received a 180-day period of marketing exclusivity.
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