Does an ANDA need to be filed for every new generic?

[Lexington2012]

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Can someone set up and manufacture a generic drug without filing an ANDA with the FDA? Is it possible to just use the formulation data that is already out there?

 

[zelman]

Can someone set up and manufacture a generic drug without filing an ANDA with the FDA? Is it possible to just use the formulation data that is already out there?

Nope.

 

[beautifulrobot]

Gotta get an ANDA to *manufacture* a generic.

*Compounding* is a different issue/can of worms.

 

[zelman]

Gotta get an ANDA to *manufacture* a generic.

*Compounding* is a different issue/can of worms.

No. Compounding a generic is straight up illegal, except in the temporary case of a shortage.

 

[lord999]

No. Compounding a generic is straight up illegal, except in the temporary case of a shortage.

Can someone set up and manufacture a generic drug without filing an ANDA with the FDA? Is it possible to just use the formulation data that is already out there?

There's a weird loophole in that which the FDA is desperately trying to close due to the public anger over how grandfathered drugs prior to the FD&C 1938 were ungrandfathered in this century (colchicine and quinine being the notorious ones). I wouldn't do a still grandfathered drug now because they are actively being targeted by FDA for USP compliance.

Also, the PQ office is not as slothful as they used to be about ANDA. Since Ted Sherwood took over that oversight (and he's quite the gung-ho bureaucrat), they've been much better about action dates in case you end up wanting to go that route.

If you want to write a PharmD paper on it, it's a great one if you're going to spend an FDA rotation. It's a highly public (to PhRMA and BIO) issue about the fairness and timeliness of review.

 

[owlegrad]

It is illegal to compound a commercially available medication, sure, but who enforces that?

 

[beautifulrobot]

No. Compounding a generic is straight up illegal, except in the temporary case of a shortage.

or if you provide it in a slightly different formulation or dosage that is not commercially available. There's all sorts of funny things with compounding.

 

[beautifulrobot]

Also, the PQ office is not as slothful as they used to be about ANDA. Since Ted Sherwood took over that oversight (and he's quite the gung-ho bureaucrat), they've been much better about action dates in case you end up wanting to go that route.

If you want to write a PharmD paper on it, it's a great one if you're going to spend an FDA rotation. It's a highly public (to PhRMA and BIO) issue about the fairness and timeliness of review.

GDUFA helped a lot with that, too. OGD was hiring people like gangbusters from 2012 up until recently (finally slowed down a bit in early 2015).

 

[zelman]

or if you provide it in a slightly different formulation or dosage that is not commercially available. There's all sorts of funny things with compounding.

....do you know what "generic drug" means?

 

[beautifulrobot]

....do you know what "generic drug" means?

yes... do you?

 

[zelman]

yes... do you?

Yes. And a "slightly different formulation or dosage" is not one.

 

[beautifulrobot]

Yes. And a "slightly different formulation or dosage" is not one.

Tomato / tomato. Sure, it doesn't meet the textbook/legal definition of a generic drug, and that's essentially how compounding pharmacies get away with it. It's hard to argue that there is any substantial difference between "bioidentical" testosterone pellets and Testopel (molecule for molecule it's the same thing), or that a levothyroxine 90 mcg tablet is not comparable to synthroid 88mcg... Those types of "slightly different formulation or dosage" changes was all I was referring to, sorry for any misunderstanding.