FDA Spells Out Procedure for ANDA Labeling Changes Without a Reference Drug

July 14, 2016

The FDA is advising generic drugmakers looking to revise their labels without the fallback of a reference product that they have only one route: supplemental submissions.

A draft guidance issued last week explains that ANDA holders looking to revise their labeling still have multiple resources to draw on when the reference product no longer exists, and recommends they file a supplement to the ANDA for all labeling changes.

For example, generic companies can look to the labeling for drugs in the same pharmacologic and therapeutic class, scientific literature and post-marketing information to find relevant content for labeling changes.

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