ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity
Draft guidance says US FDA will not assume a product has launched, the final requirement to receive the promised 180-day exclusivity, unless notified by the sponsor.
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The six months of additional exclusivity from US FDA’s CGT program appears to have kept some generic sponsors from the market, and didn’t even prompt others to enter quickly, but use of the competitive generic exclusivity program continues to grow.
Don't Assume Your ANDA Will Be Designated, US FDA Tells Aspiring Competitive Generic Therapy Sponsors
Final guidance clarifies that all sponsors who want CGT designation, which can bring exclusivity upon approval, should request it.
Advances in cancer, diabetes, and Alzheimer's could lead to expensive new treatments, contributing to spending increases in next decade, according to CMS projections.