Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. – FDA CRL

Heritage Pharmaceuticals Inc., as U.S. Agent for Emcure Pharmaceuticals Limited, received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA 205508) for Atazanavir Sulfate and Ritonavir Tablets. The FDA could not approve the application due to significant manufacturing and data reliability issues. Following a Current Good Manufacturing Practices (CGMP) inspection of the proposed new manufacturing facility, deficiencies were identified. Critically, the agency expressed concerns about the reliability of data, including previously conducted bioequivalence studies, generated at the *original* manufacturing facility, deeming previous study results insufficient. To address these deficiencies under the regulatory framework of 21 CFR 314.110, Avet Pharmaceuticals must ensure the new manufacturing facility resolves all inspectional observations, achieves CGMP compliance, and undergoes a Pre-Approval Inspection (PAI). The company is required to submit a comprehensive Chemistry, Manufacturing, and Controls (CMC) data package for a new bio-batch and conduct a new bioequivalence study using batches from the new site. Additionally, Avet must clarify its intent regarding the original manufacturing facility and its associated data. A complete resubmission addressing all issues is required within one year.