Sentences with phrase «generic imatinib»
Novartis unbelievably went as far as paying specialty pharmacies to recommend Tasigna to Medicare and Medicaid patients who were trying to fill prescriptions for other drugs (potentially generic imatinib) and to downplay the side effects of Tasigna to patients considering switching drugs.
https://www.yourlawyer.com/ Not exact matches
In a significant, yet unusual judgment the Court of Justice of the European Union (CJEU) upheld the General Court's decision (T - 140 / 12; Teva Pharma v. EMA) that had affirmed the European Medicines Agency's (EMA) rejection of Teva's generic drug application for Glivec ® (active substance - imatinib), not due to the reference product's own orphan drug exclusivity but in view of orphan drug exclusivity of a similar medicinal product — Tasigna ® (active substance - nilotinib).
However, the General Court upheld the EMA's decision refusing Teva's generic application for imatinib in view of nilotinib's orphan drug exclusivity pertaining to CML.
Teva concluded that since the approval of nilotinib was based upon an exemption granted under Article 8 (3) with regard to the first orphan product (imatinib), it should not be entitled to same scope of orphan exclusivity as imatinib and thus should not be considered a hurdle towards the approval of generics referencing imatinib.