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FDA details assessment of orally disintegrating tablets; ODTs not meant to be split
Summary
Commander Andrew Fine walked through the agency's approach to orally disintegrating tablet (ODT) petitions, noted precedent approvals and described a glycopyrrolate ODT case showing how bioavailability questions are deferred to ANDA review.
Commander Andrew Fine said dosage-form changes are the other common suitability petition and that orally disintegrating tablets (ODTs) present distinct labeling and administration issues.
"One caveat with ODT is that they are not intended to be split," Fine said, warning that if RLD labeling includes instructions to split tablets that could be a concern for an ODT petition. He noted there is precedent for ODT petition approvals (for example, a carbidopa-levodopa/Sinemet petition previously approved) and that approved ODT petitions later supported ANDAs listed in the Orange Book.
Fine discussed a glycopyrrolate ODT petition (FDA 2023 4293) where the sponsor sought 1 mg and 2 mg ODT strengths to match the RLD. He acknowledged concerns about potential bioavailability differences between ODT and oral tablets but said such bioavailability issues would be addressed in a future ANDA scientific review rather than at the petition stage.
Fine said where proposed labeling only affects dosage-form or house-supplied sections, those changes are generally permissible, but where new dosing or safety warnings would be needed, that usually supports denial at the petition stage.
