Zyban goes generic
Impax/Teva launch first generic version of GlaxoSmithKline's Zyban (bupropion 150 mg) after Andrx relinquishes 180-day marketing exclusivity. Impax' ANDA was approved March 27; under a July 2003 agreement, Andrx will share in the profits of the Impax/Teva product for six months. Andrx also gave up first-to-file rights on the compound for antidepressant use, allowing launch of Wellbutrin SR generics in March (1"The Pink Sheet" March 29, 2004, p. 27)...
You may also be interested in...
Andrx' agreement to give up its first-to-file ANDA exclusivity on a generic of GlaxoSmithKline's Wellbutrin SR 150 mg tablet means six companies will immediately share in the profits on sales of the generic antidepressant
Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination product. A new position paper explains how roles and responsibilities are shared between medtech and medicinal product experts.
A South Korean pharma firm is set to soon begin pivotal clinical trials for a hyperimmune globulin for the treatment of COVID-19 patients and plans to commercialize the product this year, with a hope of outrunning rivals including Takeda.