GSK to resubmit sNDA for Avodart to prevent prostate cancer


There have been several reports in the past few days that GlaxoSmithKline (GSK) has withdrawn its supplemental New Drug Application (sNDA) for approval to market dutasteride (Avodart) in the US for the prevention of prostate cancer, based on the results from the REDUCE trial, announced earlier this year.

GSK has indeed withdrawn the sNDA. However, the company expects to resubmit in very soon with some minor modifications, and it has already submitted these modifications to the European regulatory agency (EMEA).

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Connecting to %s

Follow

Get every new post delivered to your Inbox.

Join 333 other followers