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FDA cites $2.3M research to enable generic cyclosporin ophthalmic emulsion approvals
Summary
The presenter said CDER invested $2,300,000 in research on cyclosporin ophthalmic emulsion, which helped develop approaches for determining equivalence and led to approved generics that reduced cost and produced public-health returns.
An FDA presenter highlighted CDER's research portfolio and said in-house laboratory work allows the agency to develop product-specific guidance and address scientific gaps proactively. He pointed to cyclosporin ophthalmic emulsion as an example where research supported generic approvals and cost savings.
"We invested $2,300,000 in research to understand the product's complexities and developed appropriate approaches for determining equivalents," the presenter said, adding that resulting generics reduced costs and yielded an indirect return on the agency's public-health investment.
