FDA CRL - Abon Pharmaceuticals, LLC

This FDA Complete Response Letter (CRL) addresses New Drug Application (NDA) 210649 from AB Pharmaceuticals, LLC, acting as the U.S. Agent for Macleods Pharmaceuticals Limited, India. The application sought approval for Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 400 mg/300 mg/300 mg, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

The FDA has determined that the application cannot be tentatively approved due to significant issues identified during a recent inspection of Macleods Pharmaceuticals Limited's manufacturing facility. The inspection revealed "objectionable conditions" that require satisfactory resolution before any approval consideration.

Additionally, the FDA reserved comment on the proposed prescribing information, advising the company to review established labeling requirements and guidance documents for format and content when revisions become appropriate.

To proceed, AB Pharmaceuticals, LLC must satisfactorily resolve all observations from the facility inspection. The company is required to resubmit the application, addressing all deficiencies, or take other available actions under 21 CFR 314.110 within one year. A resubmission must be clearly marked and declare a complete response. The company may also request a meeting to discuss the necessary steps for approval. The drug product is currently ineligible for the PEPFAR program until tentative approval is granted.