Ipsen Biopharm Ltd.: relabotulinumtoxin A

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on FDA Form 483 prior to your complete response to your application.

Your complete response should include the date(s) of the facility's response to FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.

If you do not have a conditionally acceptable proprietary name, you may submit a Request for Proprietary Name Review to your IND.