FDA updates list of off-patent, off-exclusivity drugs without an approved generic

FDA

17 December 2020 - Today, the U.S. FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.” 

The list includes approved new drug applications for drug products that are not protected by patents or exclusivities at the time of the update, and for which the FDA has not approved an abbreviated new drug application referencing that new drug application product.

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Michael Wonder

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Michael Wonder