Perrigo Company has received a final Approval for Registration letter permitting the company to sell generic temozolomide in Australia.
The letter also states that bioequivalence was met between the brand product, Temodar, and the company's generic temozolomide, enabling listing on the Pharmaceutical Benefits Scheme or PBS.
Perrigo's product is the generic equivalent to Schering-Plough's Temodar, indicated for patients with malignant glioma.
Glioma is the common primary malignant brain tumor in adults, responsible for 75% of adult primary malignant brain tumors.
Perrigo chairman and CEO Joseph Papa said approval is an example of the company's geographic diversification and international capabilities.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/perrigo-wins-approval-for-generic-temozolomide-in-australia-220312