NDA 20-358: WELLBUTRIN® SR tablets

 

4)       Regarding PAWC, it should be noted that it is a theoretical value based on doses given to animals.  It realistically does not provide for a true representation of activity in humans.

 

(To be sent to the firm)

 

5)       The Division of Biopharmaceutics recommends the following dissolution specifications for all strengths of  WELLBUTRIN® SR tablets (50, 100, and 150 mg).

 

Time (hours)	%Dissolveda
1	whited out
4
8

 

6)       The sponsor should be complimented on their in vitro/in vivo correlation program.  They have put forth a good effort toward studying correlations for this SR program.

 

(Signature 3/21/95)

Safaa S. Ibrahim, Ph.D.

Pharmacokinetics Evaluations Branch I

 

Biopharm Day on March 17, 1995, attended by: Drs. T Ludden, N. Fleischer, P. Hepp, M. Chen, R. Baweja, and S. Ibrahim.

 

RD/Ft initialed by R. Baweja, Ph.D. (Signature 3/21/95)

 

cc: NDA #20-358 (Orig.), HFD-120, HFD-426 (Ibrahim, Baweja, Fleischer), HFD-427 (Chen, Chron, Drug, and Reviewer Files.

 

 

12

 

Back a Page
Next Section - Review of Original NDA
Back to Wellbutrin SR. NDA Index Page
Back to Main Index