FDA News Briefs for Monday, January 8, 2018January 8, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Expands Xgeva Approval
The FDA has granted a supplemental biologics license for Xgeva (denosumab; Amgen Inc.) to include use in prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Xgeva was previously approved for: prevention of skeletal-related events in patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. More Information.
FDA Update on IV Saline Shortage
The FDA has issued an update on drug shortages, including IV saline, resulting from the impact of Hurricane Maria on manufacturing facilities in Puerto Rico. The agency expects that the shortage of IV saline fluids will improve in early 2018. The FDA drug shortage website provides updated information regarding product availability. More Information.