Kåre Schultz, Chairman and Chief Executive Officer of Teva, spoke today during the presentation of the results for the first quarter of 2022. He provided information following the recent receipt of a Complete Response Letter (CRL ) from the FDA regarding mdc-IRM’s application for approval.
He first specified (excerpt from the presentation of the results):
“We announced a few weeks ago that we had received a CRL regarding the long-acting injectable risperidone. We will therefore respond to the questions we have received from the FDA. We expect this could result in a re-filing within six months, followed by a review period of probably six months. We still strongly believe in the concept and the effectiveness of the product. We still believe we have approval, but there will be a delay of up to 12 months. »