ANDA vs NDA: Which needs to be filed for a combo of existing drugs

[SadPharma]

If you wanted to start a pharma company and start manufacturing (not compounding) a combination of existing drugs, would you need to file an ANDA or an NDA?

For example, let's say that you wanted to manufacture a tablet with 500mg metformin and 20mg of simvastatin. As far as the FDA is concerned, this would be a new drug.

What I am confused about is whether a NDA would be necessary for combinations of drugs when each of the individual components has already been approved.

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[zelman]

If you wanted to start a pharma company and start manufacturing (not compounding) a combination of existing drugs, would you need to file an ANDA or an NDA?

For example, let's say that you wanted to manufacture a tablet with 500mg metformin and 20mg of simvastatin. As far as the FDA is concerned, this would be a new drug.

What I am confused about is whether a NDA would be necessary for combinations of drugs when each of the individual components has already been approved.

The biggest difference between NDAs and ANDAs is clinical trials that accompany NDAs (and $1.5 million). You would likely need an NDA for your example because you would need to conduct a study of the outcomes associated with your particular combination of pre existing medications and that would lead to your drug having an indication.

 

[SadPharma]

What if both of the drugs are already approved for the same indication? Off the top of my head.... something like a Pioglitazone/Metformin combo. Both are already approved for Type 2 diabetes.

 

[zelman]

What if both of the drugs are already approved for the same indication? Off the top of my head.... something like a Pioglitazone/Metformin combo. Both are already approved for Type 2 diabetes.

ACE inhibitors and ARBs are both antihypertensives. You need to study them being used together to find out how bad an idea it is.

 

[beautifulrobot]

What if both of the drugs are already approved for the same indication? Off the top of my head.... something like a Pioglitazone/Metformin combo. Both are already approved for Type 2 diabetes.

You would still need to submit an NDA showing that the combo is both efficacious (for the specific indication) and safe. As zelman mentioned, just because individually they have a favorable risk/benefit profile doesn't guarantee that they do in combination as well.