Daewoong Pharmaceutical said Wednesday that the FDA rejected Medytox’s “citizen petition” against Nabota, also known as DWP-450 and Jeuveau, on Feb. 1.
|Daewoong's headquarters in Samsung-dong, southern Seoul.|
Medytox had claimed that Daewoong and Evolus had different stories regarding the source of the Nabota strain, and requested the FDA not to approve the drug’s biologics license application (BLA) until it confirms the exact source of the strain.
The petition also requested the inclusion of full gene sequencing in the BLA of all botulinum toxin products and to disclose the origin of the Nabota strain.
“The agency reviewed the information about the source and identity of the strain used to produce DWP-450 that was submitted by Evolus as part of the BLA and concluded it was sufficient to support approval,” the FDA said. “Despite the allegations raised in the petition, we did not identify wrongful acts that would warrant invoking the application integrity policy.”
Also, regarding the petition’s request concerning the disclosure of the original Nabota strain information, such information consists of trade secrets, confidential commercial or financial information and/or manufacturing methods or processes within Evolus's BLA for DWP-450, which is not available for public disclosure, it added.
Now that the FDA rejected the U.S. company’s petition, there remain no stumbling blocks in the way to Nabota’s entry in the U.S. market, Daewoong said.
<© Korea Biomedical Review, All rights reserved.>