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505(b)(2) NDA Labeling

A draft label be included with all NDA submissions. For a 505(b)(2) NDA, where do you get the information for this label? What labeling is required?

What is labeling?

Well, the “label” is what is on the immediate container of the drug product and can contain printed or graphic information. “Labeling” is all other labels (carton, etc.) and any other written, printed, or graphic matter accompanying the drug product, including advertisements, brochures, etc. However, most people think of labeling as the package insert, containing information needed by the professional and the patient.

What does 505(b)(2) labeling look like?

The reference listed drug (RLD) labeling is always the starting point for the labeling of a new drug seeking approval through the 505(b)(2) process. Sections for the new drug labeling will differ from the RLD based on several factors. Generally, information from studies conducted by the new drug’s sponsor is added. This may include additions or replacements to sections for PK/PD, efficacy, and/or safety.

What if the RLD has no patient information leaflet?

Interestingly, even though the RLD may not currently have a patient information leaflet (PIL), the FDA may require one for a 505(b)(2) sponsor’s product. The PIL is a recent requirement for labeling that contains non-technical language so that a patient can understand the use of the medication. According to Part 208 – Medication Guides for Prescription Drug Products Sec. 208.1 (b), “The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients’ safe and effective use of drug products.” This determination can be a topic of discussion with the FDA during the NDA review process.