Dutasteride — How Long Does the Approval Process Take?

Dr Rassman!!! Hope you are keeping well…….

Just wanted to say what a wounderful job you are doing! To the question: i know the Trials for Dutasteride for hair loss has been completed. But any idea on how long before we will know if it is FDA approved, or usually how long does this process take. Are we looking at months or years? The reason i’m so keen is because, i’m a 23 year old male and i’ve been on 1mg Propecia and Regaine 5% for over a year now and havent seen any results.. Please help with some advice..

Once again many thanks

I do not know the answer to this. I was asked a similar question a couple weeks ago here.

The data is likely being analyzed after completing the phase 3 clinical trials in January of this year, and if the drug company (GlaxoSmithKline) feels that they are ready for the drug to go to the FDA, they will take it there. I don’t even know how long it will take for them to complete the analysis, as this is not my expertise. There’s a timeline for FDA approvals on Drugs.com that outlines things nicely. Avodart (dutasteride 0.5mg) was approved by the FDA years ago for treating prostate issues, but must go through a different approval process to be evaluated for the treatment of hair loss.