Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics resubmitted its Biologics License Application for LYTENAVA to the FDA for the treatment of neovascular age-related macular degeneration. The FDA accepted the resubmission as Class 1, confirming that substantial evidence of effectiveness is established and no additional trials are required.
Key figures
- Drug Name
- LYTENAVA (bevacizumab-vikg)
- Pdufa timeline
- 60 days
- Resubmission class
- Class 1
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