Par Pharmaceutical announced that the FDA has approved its supplemental Abbreviated New Drug Application (sANDA) for Bupropion HCl Extended-Release (ER) Tablets, the generic version of GlaxoSmithKline’s Wellbutrin XL.
Wellbutrin XL is a non-tricyclic antidepressant indicated for the treatment of major depressive disorder and seasonal affective disorder. It is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine, and does not inhibit monoamine oxidase or the re-uptake of serotonin.
The FDA requested all generic manufacturers marketing a version of Bupropion HCl ER 300mg Tablets to conduct a fasting bioequivalence (BE) study comparing their Bupropion HCl ER Tablets to Wellbutrin XL. In December 2012, Par submitted a sANDA containing the requested study and was later approved in April 2013.
For more information call (800) 828-9393 or visit ParPharm.com.