Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride
Recommendations for approval
Fast-track designation
Priority review
• First-time generic approval
MInocycline hydrocholride extended-release tablets in 45-mg, 55-mg, 90-mg, and 135-mg strengths (equiv to Solodyn)
LUPIN PHARMACEUTICALS
New Study Planned for Bevacizumab to Treat AMD
December 20th 2023Outlook Therapeutics plans to begin a study in the first quarter of 2024 to address the issues identified in a FDA complete response letter. If approved, Lytenava would be the only bevacizumab product to specifically treat age-related macular degeneration.