# FDA CRL - Aft Pharmaceuticals Ltd - Unknown Date

Source: https://www.globalkeysolutions.net/records/crl/aft-pharmaceuticals-ltd/21e4ef77-306d-4552-964c-c95944585fe5

> FDA CRL for Aft Pharmaceuticals Ltd on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: CRL
- Company Name: Aft Pharmaceuticals Ltd
- Product Type: Drugs
- Office Name: Office of Drug Evaluation II
- Summary: The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to AFT Pharmaceuticals, Ltd. regarding their New Drug Application (NDA) for COMBOGESIC (ibuprofen 97.5 mg/acetaminophen 325 mg) Film-Coated Tablets, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application was not approved due to multiple deficiencies across clinical, statistical, nonclinical, product quality, and manufacturing facility aspects. Key issues included insufficient description of product exposure in clinical studies and inadequate quality of statistical datasets for Study AFT-MX-6, hindering efficacy confirmation. Nonclinical concerns involved inadequate justification for a drug substance specification linked to chromosomal aberrations and a failure to address elemental impurities in accordance with ICH Q3D guidance. Product quality deficiencies cited illegible analytical chromatograms, unsupported total impurity acceptance limits, missing regulatory specifications for release and stability, and lack of BSE/TSE certification for an excipient. Additionally, the company referred to non-commercial scale batches as validation batches, requiring validation at full commercial scale per FDA guidance. A significant issue was an unsatisfactory inspection at a manufacturing facility (COG), where product/process controls, lab controls, and quality assurance functions were found unacceptable. To address these, AFT Pharmaceuticals must provide detailed exposure data, re-analyze efficacy datasets, revise drug substance specifications, conduct elemental impurity analysis, update analytical procedures and specifications, provide excipient certifications, confirm commercial-scale process validation, resolve all facility observations, and submit a comprehensive safety update.

## Related Documents

- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/aft-pharmaceuticals-ltd/60a1e29b-bf71-4753-bcc8-a73aa8e92301)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/aft-pharmaceuticals-ltd/eba71bf9-500a-4370-adb2-90ad0c8bde41)

## Related Officers

- [David Zuchero, MS, JD](https://www.globalkeysolutions.net/people/david-zuchero-ms-jd/0468664e-517d-4d9e-847b-c0505f82c7bd)

Company: https://www.globalkeysolutions.net/companies/aft-pharmaceuticals-ltd/8ec1a007-17bf-4853-9805-6dc64001e836

Office: https://www.globalkeysolutions.net/offices/office-of-drug-evaluation-ii/1a4f7041-7863-48dd-8621-0707564d3724