Liquid Presentation of Leucovorin Calcium Now Available
This is currently the only liquid formulation of this agent available in the US.
Cytoprotective and Supportive Care Agents
Xgeva Approved to Prevent Skeletal-Related Events in Multiple Myeloma Patients
The approval is based on data from the pivotal Phase 3 ‘482 study, the largest international multiple myeloma clinical trial ever conducted.
Certain Sandostatin Strengths Discontinued
The decision to discontinue Sandostatin 200mcg and 1000mcg is not due to manufacturing, product quality, safety, or efficacy concerns, according to the Company.
Cytoprotective Agent Ethyol Now Available
Cumberland announced the relaunch of Ethyol (amifostine) for Injection indicated to reduce the incidence of xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, and to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
FDA Approves Updated ONJ Warning for Prolia, Xgeva
The Food and Drug Administration (FDA) has approved supplemental Biologics License Applications (sBLA) for Amgen’s Prolia (denosumab) and Xgeva (denosumab).
First Emergency Tx Approved for 5-FU, Capecitabine Overdose
The FDA has approved Wellstat Therapeutics’ Vistogard (uridine triacetate) oral granules, the first treatment for patients following an overdose of 5-fluorouracil (5-FU) or capecitabine,
Adjunctive Telotristat Demonstrates Efficacy in Carcinoid Syndrome
Lexicon announced top-line results from the Phase 3 study, TELESTAR, which evaluated oral telotristat etiprate in cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care.
Pulmonary HTN Reported With Proglycem in Newborns, Infants
The Food and Drug Administration (FDA) has issued a warning that pulmonary hypertension has been reported in infants and newborns treated with Proglycem (diazoxide; Teva) for low blood glucose.
Cannabis Helpful for Cancer-Linked Symptoms, But Quality Studies Needed
Cannabis and cannabinoid pharmaceuticals can be helpful for nausea and vomiting, pain, and weight loss associated with cancer.
Xgeva Gains Hypercalcemia of Malignancy Indication
Amgen announced that the Food and Drug Administration (FDA) has approved Xgeva (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
