NexMed receive non approvable letter for topical alprostadil

NexMed have received a non approvable letter from the US FDA in response to its NDA for its topical alprostadil product Alprox-TD for for the treatment of erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.

About these ads

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 )

Google+ photo

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

Connecting to %s

Follow

Get every new post delivered to your Inbox.

%d bloggers like this: