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.
Generic Line