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# FDA OKs TE Code for Paclitaxel Suspension
- URL: https://www.fdaweb.com/fda-oks-te-code-for-paclitaxel-suspension/
- Published: 2024-05-07T12:00:00.000Z
- Updated: 2026-09-14T14:30:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156931

Responding to an 8/30/2022 petition submitted by HBT Labs, FDA says it has determined that cancer drug paclitaxel particle bound particles for injectable suspension (albumin-bound) 100 mg/vial and Abraxane (paclitaxel protein bound particles for injectable suspension) are pharmaceutically equivalent and bioequivalent, and can be expected to have the same clinical effect and safety profile when administered under the conditions specified in their labeling. Thus, the agency [says](https://downloads.regulations.gov/FDA-2022-P-2075-0005/attachment%5F1.pdf?ref=fdaweb.com), it is granting part of the petition’s request and is approving an AB therapeutic equivalence (TE) code for paclitaxel protein bound particles for injectable suspension (albumin-bound) 100 mg/vial.

The petition had requested an AP TE code, but FDA says it determined that an AB code was appropriate.

The petition also claimed that a TE code would allow HBT to be exempt from, or otherwise get a refund of, any PDUFA annual program fees FDA may assess on the paclitaxel NDA for Fiscal Year 2023 and thereafter. The agency response says that while it agrees that paclitaxel qualifies for the pharmaceutically equivalent exception to annual PDUFA program fees, applicants must submit a written request for a return of program fees not later than 180 calendar days from the date the fee is due. “This is the case even if the applicant has submitted a citizen petition that may relate to a potential claim for a refund,” the FDA response says.