- 21 health industry groups address FDA on proposed changes to generic drug label rules
- Senate passes Drug Quality and Security Act
- Indiana Senate passes generic biologic pathway legislation
- Roxane Labs' generic prostate drug gets tentative approval from FDA
- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.
Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.
Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.