Biopharmaceutical company AstraZeneca has announced agreement with the US Food and Drug Administration (FDA) with regard to FASLODEX (fulvestrant) Injection label changes.
The labeling update includes results and a Kaplan-Meier plot of the final overall survival (OS) evaluation from CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic breast cancer), the key study that supports FASLODEX 500mg.
The updated label also includes information from an additional two-year carcinogenesis study, which has been conducted in rats and mice.
AstraZeneca, which operates in over 100 countries, primarily focuses on the discovery, development and commercialization of prescription medicines.
Source:
http://pharmaproducts.packaging-business-review.com/news/astrazeneca-updates-faslodex-injection-labeling-061212
