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# FDA Denies Belbuca Petition
- URL: https://www.fdaweb.com/fda-denies-belbuca-petition/
- Published: 2022-03-22T12:00:00.000Z
- Updated: 2026-09-14T17:37:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151420

FDA has denied a 10/21/21 petition submitted by BioDelivery Sciences International, Raleigh, NC, asking the agency to take certain actions on applications for follow-on buprenorphine buccal film products. Specifically, the petition asked that the agency: 

- require any applicant for a low or high pH buprenorphine buccal film product citing BioDelivery’s Belbuca (buprenorphine buccal film) as the reference-listed drug to include in the application adequate safety data, including data from the relevant patient population, from a comparative clinical investigation using relevant safety endpoints;
- refuse to approve an ANDA and require submission of a 505(b)(2) NDA to the extent that FDA determines that other than “limited confirmatory testing” evidence is needed to address pH safety concerns; and
- revise the agency’s product-specific bioequivalence guidance for generic Belbuca and issue guidance for the approval of oral mucoadhesive films that address the pH concerns discussed in the petition.

The FDA 3/18 denial [letter](ttps://downloads.regulations.gov/FDA-2021-P-1142-0003/attachment%5F1.pdf) says the BioDelivery petition **(1)** did not provide any scientific support for its assertion that follow-on products with a different pH range than Belbuca’s will result in local irritation or changes in bioavailability due to local irritation; **(2)** did not demonstrate that studies of temperature and pH of liquids are necessary; and **(3)** did not demonstrate that the draft buprenorphine hydrochloride buccal film product-specific guidance should be revised or that guidance for oral mucoadhesive films to address pH concerns is necessary.