November 23, 2001 - The FDA has approved Dutasteride for use in treating "the signs and symptoms of benign prostatic hyperplasia."

The tentative approval was issued on November 20, 2001. At this time there is no other documentation available giving more details but we will add them as soon as they become available.

The approval was expected as Glaxo had previously indicated that they were anticipating approval in November or December of 2001. Glaxo submitted the new drug application (NDA) for Dutasteride in the 4th quarter of 2000 and a marketing approval application (MAA) was submitted in the 3rd quarter of 2001. Now that it has been approved Glaxo will be requested to submit a supplemental new drug application (sNDA) that includes 2 year's worth of additional data following up the patients who have been using the drug.

After the approval process the FDA sends the drug company a letter requesting additional information from them such as an example of the packaging and marketing materials, package inserts, etc. The FDA has to approve all aspects of the drug including how its marketed so consumers should not expect the drug to be available until early 2002. (click here to see an example of the type of information the FDA requests [PDF format])

At a previous presentation done for financial analysts Glaxo stated that the results of the BPH trials will be announced at the European Association of Urology meeting in February 2002. This is where the drug will most likely be launched since it is a prostate drug. We don't anticipate it being available to consumers before then.

Once it is available doctors can prescribe it for consumers for hair loss as the FDA allows any drug to be prescribed for any other purpose under its 'off label' use laws. According to unconfirmed sources, Glaxo submitted data for a 0.5mg dose as well as a 2.5mg dose so its not known yet which dose is going to be available or if both doses will.

As far as Dutasteride being made available as a hair loss drug, we have seen some information that Glaxo is planning on submitting a NDA for use as a hair loss drug in 2002. However this cannot take place until Glaxo completes Phase 3 studies for hair loss. At this time we are unaware of any activity taking place that would indicate Phase 3 hair loss studies are underway. Most people believe that Glaxo will first see how people respond to Dutasteride as there is some concern about the sexual side effects based on Dutasteride's ability to suppress much more DHT than Finasteride. At this time there is insufficient information to determine if this will be a factor or not.