Home » FDA Grants Final Approval for Generic Risperdal
FDA Grants Final Approval for Generic Risperdal
The FDA has granted final approval to Teva Pharmaceutical Industries’ ANDA for its generic version of Ortho-McNeil-Janssen Pharmaceuticals’ antipsychotic agent Risperdal 1-mg/mL oral solution. As the first company to file an ANDA for generic Risperdal (risperidone) with a Paragraph IV certification, Teva has 180-day marketing exclusivity on the product, which Teva says it has begun shipping.
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