Femara receives FDA nod for new indication
Novartis has been given the OK to market its aromatase inhibitor, Femara (letrozole), as a treatment for use after surgery in postmenopausal women with hormone-sensitive early breast cancer. Approval of the new indication was based on results from the Breast International Group (BIG 1-98) study, which showed an additional 21% reduction in risk for cancer recurrence over tamoxifen therapy and a 27% reduction in the risk of cancer metastases to distant parts of the body. The drug was given a six-month priority review.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
