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# FDA Partially Approves Teva Petition on Generic Amrix
- URL: https://www.fdaweb.com/fda-partially-approves-teva-petition-on-generic-amrix/
- Published: 2016-11-28T12:00:00.000Z
- Updated: 2026-09-14T21:50:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137430

FDA has partially approved a Teva petition that sought tighter bioequivalence on generic copies of its skeletal muscle relaxant Amrix (cyclobenzaprine hydrochloride), 15 mg and 30 mg extended-release capsules. The agency agreed with Teva’s contentions that generic applicants must demonstrate that their proposed ANDA product is bioequivalent to Amrix when each product’s capsule contents are administered by sprinkling on applesauce. Because Amrix capsules are labeled for sprinkling on applesauce and there is no exclusivity or method of use patent listed for suchuse, an ANDA referencing Amrix would need to include this method of administration in its labeling, the agency said in a just-released letter to Teva. “Thus, an ANDA applicant should conduct a study demonstrating bioequivalence when both the proposed ANDA and RLD \[reference-listed drug\] capsules are opened and sprinkled on applesauce.”

In the [letter](https://www.regulations.gov/document?D=FDA-2016-P-1873-0007&ref=fdaweb.com), the agency dismissed Teva’s request that ANDAs use beads of a similar size to the RLD. “While FDA recommends that the beads contained in an applicant’s drug product fall within the target size range provided in the guidance, the guidance’s recommendations address the possibility of beads that are larger than the maximum recommended size of 2.8 mm,” FDA said. “If the applicant’s proposed bead size is greater than that recommended in the guidance, the applicant should provide justification for the bead size, including studies demonstrating that the beads can be swallowed without chewing when administered to the intended population by sprinkling over applesauce.”

In addition, FDA said it does not agree that the beads contained in an ANDA capsule must be similar in size to the beads contained in the RLD capsule. “The agency does not evaluate the appropriateness of a proposed generic capsule’s bead size based solely upon comparison to the RLD’s bead size,” the letter said. “Instead, FDA considers the impact of any differences in bead size between the RLD and generic product during the application review process to determine whether these differences may affect bioequivalence, may affect administration of the product, or may affect patient compliance. Although the targets and maximum sizes provided in the Bead Size Guidance are recommendations, FDA will not approve capsules for the sprinkling method of administration if the capsule contents cannot be administered as directed in the labeling.”