Luye Pharma Group (HKG: 2186), a Chinese pharmaceutical company, has announced that it has successfully passed the Pre-Approval Inspections (PAI) by the U.S. Food and Drug Administration (FDA) for its manufacturing facility producing paliperidone palmitate extended-release injectable suspension (LY03010). The inspection was completed without any Form 483 Inspectional Observations, indicating compliance with the FDA’s standards.
Paliperidone palmitate, a second-generation antipsychotic medication available in both oral and long-acting injectable forms, is utilized for the treatment of schizophrenia and schizophrenic affective disorders. The company’s New Drug Application (NDA) for the drug was submitted to the FDA through the 505(b)(2) pathway, which is designed for drugs that improve upon previously approved medications. Passing the PAI is a significant step forward in facilitating the review and potential approval of the drug in the U.S. market.- Flcube.com
