The affected product is Budeprion XL 300 mg, manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA--one of the five generic versions of Wellbutrin XL
300-mg tablets that have been approved by the FDA.
Biovail (TSE: BVF) makes Wellbutrin XL
, a widely prescribed anti-depressant, and Ultram ER, an extended-release formulation of an anti-pain medicine.
Revenue from the antidepressant Wellbutrin XL
surged to $58.
The researchers also found that they could predict whether subjects were more likely to respond to a different antidepressant, bupropion, also known as Wellbutrin XL
GlaxoSmithKline's unique dual-acting treatment option for major depressive episodes, Wellbutrin, is currently available as a once daily extended-release tablet, Wellbutrin XL
In addition, GSK continued to face notable exposure to generic competition in the key US market with the Wellbutrin XL
, Zofran and Coreg IR brands all cited as generic sales casualties.
A lot will depend on the timing of generic competition to Wellbutrin XL
, but we see no reason to change our positive view of the shares.
The main focus on Thursday will be on the management's guidance for this year, as there are likely to be several generic challenges to core products, including Zofran - used to prevent nausea and vomiting associated with chemotherapy - and Wellbutrin XL
, which treats depression.
However, pharmaceuticals firm GlaxoSmithKline found itself going in the other direction following a US court ruling which could open the door to a generic version of its antidepressant pill Wellbutrin XL
However, pharmaceuticals firm GlaxoSmlthKline found itself going in the other direction following a US court ruling which could open the door to a generic version of its antidepressant pill Wellbutrin XL
Extended-release bupropion is marketed as Wellbutrin XL
In a correspondence issued December 2012, FDA requested all generic drug companies marketing a version of Bupropion HCl ER Tablets, 300 mg, to conduct a fasting bioequivalence (BE) study comparing their Bupropion HCl ER tablets, 300 mg, to GSK's WELLBUTRIN XL
(Bupropion Hydrochloride Extended-release) Tablets, 300 mg.