NDA 21-515                                         Approval Letter                                                 6

 

 

from the proprietary and established names of the drug as well as from the dosage strength(s).

4.       The statements “Sample – Not for Sale” and “Patient Sample Kit” should be moved to the bottom of the front panel so that they do not distract from the proprietary and established names of the drug as well as the dosage strengths(s).

D.     Shipping Carton (Contains 4 Sample Kits)

1.       See comments C.1. through C.5., above.

 

Promotional Materials

In your complete response to this letter, please also submit three copies of the introductory promotional materials that your propose to use for this product.  Please submit all material in draft or mock-up form rather than final printed format.  Please send one copy to this Division and two copies of both the promotional material and the package insert directly to:

 

Division of Drug Marketing, Advertising, and Communications, HFD-42

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

 

Options Under 21 CFR 314.110

Within 10 (ten) days after the date of this letter, you are required to amend the application, notify us of your intent to file an amendment, or follow one of your other options under 21 CFR 314.110.  In the absence of any such action, FDA may proceed to withdraw this application as provided for under 21 CFR 314.65.  Any amendment should respond to all the comments and requests in this letter, including those incorporated by reference.  We will not process a partial reply as a major amendment, nor will the review clock be reactivated, until all deficiencies have been addressed.

 

Opportunity for Informal Meeting Under 21 CFR 314.102(d)

Under 21 CFR 314.102(d), you may request an informal meeting or telephone conference with the Division of Neuropharmacological Drug Products, to discuss what further steps need to be taken before the application may be approved.

 

This drug product may not be legally marketed until you have been notified in writing that this application has been approved.

 

 

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