Capture

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

  • To improve transparency and encourage the development and submission of  ANDAs in markets with limited competition
  • Part I of the list identifies those drug products for which FDA could immediately accept an ANDA without prior discussion
  • Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA

LEARN


Image credit: FDA

Advertisements

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