FDA CRL - CMP DEVELOPMENT LLC

The FDA issued a Complete Response Letter (CRL) to CMP Development LLC for its New Drug Application (NDA 214439) for NORLIQVA (amlodipine) Oral Solution 1 mg/mL, indicating the application cannot be approved in its current form. Under the regulatory framework of section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, the main violations and issues identified include unresolved manufacturing facility deficiencies from a recent inspection, objectionable conditions noted during record reviews at other sites, and an uncompleted pre-approval inspection for another facility due to travel restrictions. Further issues encompassed product quality, specifically the need to establish acceptance criteria for commercial production testing based on development data rather than initial commercial batches, and a requirement for a comprehensive safety update. The required actions include satisfactory resolution of all manufacturing deficiencies, completion of the outstanding inspection, revised product quality data, an updated safety profile encompassing all nonclinical and clinical studies with specific data presentation, and re-submission of the proprietary name. CMP Development LLC must address these deficiencies and resubmit the application within one year.