Actavis’ Bioequivalence Data Still Missing For Bupropion XL

Could the nearly five-month delay in submitting FDA mandated bioequivalence tests signal something is wrong with its two 300 mg bupropion generics?

Allergan PLC refuses to comment on what has caused a five-month-and-counting delay on FDA-required bioequivalence testing for its two 300 mg generic versions of GlaxoSmithKline PLC’s antidepressant WellbutrinXL (bupropion), opening the door to questions as to whether the company is simply late or whether there may be equivalence problems lurking for the drugs.

FDA requested the bioequivalence tests in 2012 after it determined that the 300 mg bupropion generic formally marketed by