Video
Incentives for Filing a Product Through the 351(k) Pathway
Steven Lucio of Novation discusses how Teva's Granix (tbo-filgrastim), which was filed through a 351(a) pathway, was approved for only 1 indication--and it was not the indication considered to be the "most definitive" for that particular product.
Steven Lucio of Novation discusses how Teva's Granix (tbo-filgrastim), which was filed through a 351(a) pathway, was approved for only 1 indication--and it was not the indication considered to be the "most definitive" for that particular product. As a result, uptake of this product may be affected, says Lucio. Conversely, within the 351(k) structure, companies would potentially be able to extrapolate across indications.
This video was shot at the 2013 Academy of Managed Care Pharmacy in San Antonio, Texas.
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