The failure of an extended-release form of generic Wellbutrin (bupropion) to perform as well as its brand-name counterpart has prompted the FDA to take a closer look at the way all extended-release generics are made, reports the New York Times.

“This has actually prompted us to change our policy,” Gregory P. Geba, director of the FDA’s office of generic drugs, told the Times in an interview.

While generic drugs are required to have the same active ingredient as brand-name versions, critics say that manufacturers of generics do not always succeed in designing ways to deliver extended-release formulations, and the FDA has been slow to act on this.

The 300-mg formulation of extended-release bupropion made by Impax Laboratories was pulled from the market in October after an FDA analysis found that it was not therapeutically equivalent to Wellbutrin XL 300 mg.

Source:  New York Times