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FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for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.
FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for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.
The guidance recommends that the dosage amount meant to be achieved by splitting a tablet should not be below the minimum therapeutic dose indicated on the approved labeling. Scoring should not pose a risk of unintended drug exposure (e.g., to chemotherapeutic agents or hormones). Modified-release products should not have a scoring feature if the control of drug release could be compromised by tablet splitting, according to the guidance. Such products may include tablets controlled by an osmotic-pump system or an exterior film coat.
The guidance also recommends that the split tablet meet established stability requirements for 90 days at 25 ± 2 °C and 60% ± 5% relative humidity when stored in standard high-density polyethylene pharmacy bottles and caps. The split portions of the tablet should meet the same finished-product testing requirements as those for a whole-tablet product with equivalent strength, according to the document. In addition, FDA recommends that the scoring configuration of generic drug products be the same as that of their reference products.
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