FDA Issues Guidance on Physical Attributes for Oral Generic Drugs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-19-2015 17:46


The US Food and Drug Administration (FDA) has issued final guidance, Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules: Guidance for Industry, to recommend to generic drug manufacturers that they consider consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates.

The recommendations in the guidance apply to abbreviated new drug applications (ANDAs) and their supplements for additional strengths that are submitted to the Office of Generic Drugs.The guidance does not apply to approved abbreviated new drug applications (ANDAs) for generic drugs already on the market. However, the FDA said that if the agency determines that an approved product should be modified because the size or shape of a product poses a risk to public health, it will notify the holder of the ANDA. The guidance also is not intended to apply to other oral dosage forms (e.g., chewable tablets, oral tablets for suspension /solution, orally disintegrating tablets, sublingual tablets, troches, or gums).

FDA outlined its rationale for the guidance. "While generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD), we are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors. We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates."

In addition to the size and shape of the tablets and capsules, the FDA guidance said that other physical attributes of tablets and capsules should be considered in the context of their effect on ease of swallowing. The guidance says that tablet coating, weight, surface area, disintegration time, and propensity for swelling should be considered when developing a QTPP for generic tablets.

Source: FDA


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