FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets. The document also describes nomenclature and labeling, and is intended to facilitate the evaluation of these products.
Insurance companies and doctors are increasingly recommending that patients split tablets to adjust the dose or reduce costs, according to the guidance. In response, the Center for Drug Evaluation and Research’s Drug Safety Oversight Board held meetings in October 2009 and November 2010 to discuss tablet splitting. FDA’s internal research indicated that tablet splitting could raise safety concerns, especially when tablets are not scored or evaluated for splitting. The safety concerns include variations in tablet content, weight, disintegration, or dissolution. Tablet splitting also may affect product stability, according to the document.
FDA has considered tablet scoring when determining whether a generic drug is the same as the reference product. If a generic product and its reference product are scored consistently, then the patient can adjust the dose the same way, no matter which product he or she uses. Consistent scoring also would ensure that neither the generic nor the reference product had an advantage in the marketplace.