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Briarcliff767
Briarcliff767, FDA-expert
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A combination of 2 old, FDA approved medications is being

Customer Question

A combination of 2 old , FDA approved medications is being used for a new diagnosis , this combination has been safely used for other indications . Now a study is being done to evaluate its efficacy . IF proven effective ( it being made in the compounding pharmacy ) and a Pharma like Glaxo wants to make it do they have to repeat the study or if they use same processes no need to repeat the study ?
Submitted: 11 months ago.
Category: FDA
Expert:  DocPhilMD replied 11 months ago.

They will need to repeat the study for sure

They will need to prove the combination has the same or better effect

Expert:  Briarcliff767 replied 11 months ago.

Hi my name is ***** ***** I am happy to assist you. I have assisted many companies with getting FDA approvals and classifications. If they are using the same study that has already need approved they do not need to repeat this. Both medications are already approved all you will need to do is add this to the current study that has the approval. You will need to send in the reports of how your are combining the 2 medications. So all they need to do is use the same study and send in that report.

Expert:  DocPhilMD replied 11 months ago.

If it is a new diagnosis, then I'm sure a new study has to be done

Expert:  Briarcliff767 replied 11 months ago.

Hi just checking in to see if you still need further assistance ?

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