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# Revance Re-files BLA for DaxibotulinumtoxinA
- URL: https://www.fdaweb.com/revance-re-files-bla-for-daxibotulinumtoxina/
- Published: 2022-03-08T12:00:00.000Z
- Updated: 2026-09-14T17:35:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151320

Revance Therapeutics has resubmitted its BLA for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar lines, in response to a 10/21 Complete Response Letter. The company says the submission adheres to input it received 12/2021 during a Type A meeting. Specifically, it says it contains information on the “subsequent completion of the production of three consecutive drug substance lots and one drug product lot as part of the qualification of a new working cell bank (WCB), which was required by the FDA to address the outstanding observations related to the WCB and the drug substance manufacturing process.” FDA reportedly told the company that the qualification will need to be verified by a reinspection of the firm’s manufacturing facility.

In 10/2021, FDA released a [7/2/2021-dated FDA-483](https://www.fda.gov/media/153014/download?ref=fdaweb.com) with five inspection observations issued following a  
6/21-7/2/2021 inspection at the firm’s Newark, CA drug substance and drug product manufacturing facility. The inspection observations were:   

- current release and stability cell bank testing methods are insufficient to monitor quality and shelf-life of working cell bank;
- the current manufacturing process is not the process proposed for licensure;
- the firm’s quality unit lacks the responsibility and authority for the control, review, and approval of outsourced activities, which includes defining the responsibilities and communication processes for quality-related activities in a written agreement;
- actual yield and percentages of theoretical yield, indicators of process performance, are not determined after each appropriate phase of manufacturing for a redacted drug product; and
- the responsibilities and procedures applicable to the quality control unit are not always in writing.

DaxibotulinumtoxinA is the company’s next-generation neuromodulator product that “combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components,” Revance says. DaxibotulinumtoxinA is also being evaluated in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications — cervical dystonia and adult upper limb spasticity.