Outlook Therapeutics Inc (OTLK)

[pfelgueiras]

ONS-5010 (bevacizumab-vikg), for treatment of wet AMD, 12 years market exclusivity under new BLA.

FDA has taken hundreds of unapproved prescription drugs off the market since 2006 and has executed multiple class actions announced through Federal Register Notices.

FDA does not remove an unapproved drug used to treat serious medical conditions until a sufficient and reliable supply of FDA approved drug is available.

FDA Actions to Remove Unapproved Drugs from the Market by Company

https://www.fda.gov/drugs/enforcement-activities-fda/fda-actions-remove-unapproved-drugs-market-company