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Abbreviated New Drug Application

Abbreviated New Drug Application

Search complete. 4 mentions across 2 episodes found for "Abbreviated New Drug Application".

Sep 15, 2026

Steve SmallHOST
2:55
Exactly right.
Steve SmallHOST
2:56
And very briefly, when a brand manufacturer creates a new med, they submit something called a new drug application or an NDA to the FDA after completing, obviously, clinical trials to prove the drug's safety and effectiveness, which we're all used to, right? Now, generic manufacturers can submit an abbreviated new drug application or ANDA to to market their drug after the brand's patent expires.
Steve SmallHOST
3:20
And it's abbreviated because the generic company doesn't need to repeat all those costly safety and effectiveness studies, although they do need to prove that the med is absorbed to the same rate and extent.
Don WeinbergerHOST
3:31
Well, lucky them.
Don WeinbergerHOST
7:24
Correct.
Don WeinbergerHOST
7:25
And traditional generics can have different enacting ingredients like things like binders and fillers and dyes.
Don WeinbergerHOST
7:31
And going back to what you said about NDAs from the legal side, authorized generics are sold under the brand products existing NDA, not a separate ANDA like we talked about with traditional generics.
Don WeinbergerHOST
7:43
Good point.
Joshua FritzlerGUEST
15:42
well? So we don't actively do that.
Joshua FritzlerGUEST
15:44
What I believe you're referring to is an ANDA.
Joshua FritzlerGUEST
15:46
So it's an abbreviated new drug application where we'd be able to help either a brand of manufacturer or big pharma kind of create that drug for trials.
Joshua FritzlerGUEST
15:55
We are not involved in that currently, but there's definitely manufacturers that do aid in that.

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