Budeprion

Most recently Mr. Graedon has been hearing complaints on his Web site about generic forms of the antidepressant Wellbutrin XL 300 (known as Budeprion XL 300 in one generic form), the heart medicine Toprol XL (metoprolol succinate) and the antiseizure medicine Keppra

NYT > Home Page 2009

Bioequivalent Deborah Jaskot, vice president for regulatory affairs at Teva Pharmaceuticals USA, which distributes Budeprion, says the ConsumerLab dissolution test was an invalid comparison, and that on all the accepted tests, Budeprion performed within the range of bioequivalence with Wellbutrin.

Inexact Copies: How Generics 2008

He also asked ConsumerLab. com, which normally runs tests for dietary supplement manufacturers, to compare Budeprion and Wellbutrin.

Inexact Copies: How Generics 2008

Many patients switched from Wellbutrin XL 300 mg to Teva's Budeprion (right); a few have gone back.

Inexact Copies: How Generics 2008

But they were more alarmed to read in the report that the FDA relied on tests comparing a lower dose of Wellbutrin and Budeprion -- 150 mg -- when it first approved the 300 mg version in 2006, and didn't have specific bioequivalence data on the 300 mg dose that had generated the complaints.

Inexact Copies: How Generics 2008

The truth, however, is that a bioequivalence study has never been performed on Teva's Budeprion XL 300.

Generics Are Not Necessarily the Same as Brands 2008

The ConsumerLabs. com finding that the generic Budeprion dissolves faster than the branded Wellbutrin is misleading.

Generics Are Not Necessarily the Same as Brands 2008

Complaints about Budeprion also were coming into the FDA -- at least 130 from December 2006 to January 2008, according to Andy Georgiades of Dow Jones News Service, who filed a Freedom of Information Act request.

Inexact Copies: How Generics 2008

The article notes a Teva spokeswoman saying that the test was an "invalid comparison, and that on all the accepted tests, Budeprion performed within the range of bioequivalence with Wellbutrin."

Generics Are Not Necessarily the Same as Brands 2008

Teva itself has received 101 reports of problems with Budeprion -- out of 4.5 million prescriptions written -- and hasn't heard reports of unusual smells, a spokeswoman says.

Inexact Copies: How Generics 2008