Medications: Guidance on Tablet Scoring Cheat Sheet (DRAFT) by [deleted]

This document provides guidance for NDAs and ANDAs having tablets that have been scored. It provides:
Guidelines to follow, data to provide, and criteria to meet and detail in an applic­ation to support approval of a scored tablet.
Nomenc­lature and labeling for approved scored tablets

This guidance does not address specific finished product release testing, where additional requir­ements may apply to scored tablets.

A score is a useful feature for the patient who, for instance, wants to switch from a name-brand to generic product and may need to halve tablets to maintain a consistent dosage regimen. By some accounts, this is happening more often, as insurance companies and doctors are increa­singly recomm­ending that patients split tablets for proper dosing or sometimes as a cost saving measure.

Scoring has also been an issue in determ­ining whether a generic drug is equivalent to its reference product. Whether or not a tablet is scored (and scored properly) can play a role in the cat-an­d-mouse game that origin­ating manufa­cturers play with would-be generic compet­ition. A reference drug may have a well-d­efined score while a generic product may only have a cosmetic breakl­ine—in such a case, is the generic truly equiva­lent?

Scoring of tablets facili­tates the splitting of tablet into fractions when less than a full tablet is desired for a dose. (For adjusting the dose in the same manner as the RLD) Although there are no standards or regulatory requir­ements that specif­ically address scoring of tablets, Agency recognizes the need for consis­tency scoring between a generic product and its RLD. Agency concluded that tablet splitting have safety issues in some cases. Concerns with splitting of tablet include variations in the tablet content, weight, dissol­ution or disint­egr­ation. In addition, there may be stability issues with splitting tablets. How much drug is present in split tablet and available for absorption

The draft guidance’s fundam­ental guidelines and criteria are:

1. The dosage amount meant to be achieved after splitting the tablet should not be below the minimum therap­eutic dose indicated on the approved labeling.
2. The scored dosage form should be safe to handle and not pose risk of unintended drug exposure.
3. Modified release products for which the control of drug release can be compro­mised by tablet splitting should not have a scoring feature.
4. The split tablet, when stored in standard high-d­ensity polyet­hylene pharmacy bottles and caps (no seal), should meet establ­ished stability requir­ements for a period of 90 days at 25º C, plus or minus 2º C/60 percent Relative Humidity (RH), plus or minus 5 percent RH.
5. The split tablet portions should meet the same finish­ed-­product testing requir­ements as for a whole-­tablet product with equivalent strength. A risk assessment should be provided to justify the tests and criteria for product with the proposed functional score.
6. The scored tablet should be tested using the indicated patient population to ensure patients can split the tablet correctly, as labeled.
7. The scoring config­uration of generic drug products should be the same as the reference drug.
8. New study data on tablet splita­bility should be provided during postap­proval for any product changes per FDA’s SUPAC guidances.

New products that meet the above-­ref­erenced criteria can be labeled as having functional scoring. Such labeling should appear in all of the following sections of the prescr­ibing inform­ation:

• “Dosage Forms and Strength” section of the Highli­ghts.
• “Dosage Forms and Strength” section of the Full Prescr­ibing Info.
• “How Supplied” section of the Full Prescr­ibing Inform­ation.