Name: Lytenava (bevacizumab-vikg) in Neovascular age-related macular degeneration: Ongoing post-approval monitoring
Published: 2026-09-28T12:24:10-04:00

Product information and disease description Place of product in therapy Approaches to treatment

Ongoing post-approval monitoring

3 evidence topics · 1 source

Adverse experience and distribution reporting

“You must submit adverse experience reports under the adverse experience reporting requirements at 21 CFR 600.80.” (opens the source at this quote in a new tab)
“You must submit distribution reports under the distribution reporting requirements at 21 CFR 600.81.” (opens the source at this quote in a new tab)

Biological product deviation reporting

“You must submit reports of biological product deviations under 21 CFR 600.14. You should promptly identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution.” (opens the source at this quote in a new tab)

Manufacturing change control

“Any changes in the manufacturing, testing, packaging, or labeling of Lytenava, or in the manufacturing facilities, will require the submission of information to your BLA for our review and written approval, consistent with 21 CFR 601.12.” (opens the source at this quote in a new tab)