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FDA issues Guidance on Tablet Scoring
The US Food and Drug Administration (FDA) has published a new final guidance document on the criteria that sponsors of new and abbreviated drug applications (NDA/ANDA) should use to evaluate tablet that have been scored to allow for the product to be split into two or more pieces.
One characteristic of a tablet dosage form is that it may be manufactured with a “score” or “scores,” a score being a debossed line running across the planar surface of the tablet. This characteristic is useful because the score can be used to facilitate the breaking of the tablet into fractions when less than a full tablet is required for a dose. Although there are no standards or regulatory requirements for scoring of tablets, with the passage of the Waxman-Hatch Act, the Agency recognized the need for consistent scoring between the generic product and the reference listed drug.
Consistent scoring assures that the patient is able to adjust the dose, by breaking the tablet, in the same manner as the listed drug. This enables the patient to switch between manufacturers of the same product without encountering problems related to the dose. Additionally, consistent scoring assures that neither the generic product nor the listed drug may have an advantage in the marketplace because of the score. Such advantage would be contrary to the intent of Waxman-Hatch.
For many years OGD has recognized the importance of having the scoring configuration of generic tablets be the “same as” that of the reference listed drug. It is the intent of this guide to provide further clarification of what is meant by “same as” with regard to scoring of generic drug products.
The scoring configuration of a generic tablet should be the same as that of the listed drug. This should be evident, in terms of the exhibit batch, when the application is submitted to OGD. Specifically:
- If the listed drug is scored, the generic tablet should be scored to produce partial doses equivalent to that of the listed drug.
- If the listed drug is not scored, the generic drug should not be scored.
- If the scoring configuration of the exhibit batch does not match that of the listed drug, the generic firm will be requested to provide a commitment, prior to the application’s approval, not to market the product until it is correctly scored.
FDA’s guidance also notes that new products meeting the criteria for scoring should be labeled as having “functional scoring,” and labeling to that effect should appear in the “Dosage forms and strength” section of the highlights and full prescribing information sections of the labeling. In addition, the “How Supplied” section of the full prescribing information should also contain scoring information.
“In this way, the use of the term functional scoring in the labeling can communicate to healthcare providers that the product has been evaluated against the established criteria,” FDA concluded.