Important pharmacy news and late-breaking industry information updated daily.
FDA Commissioner Scott Gottlieb, MD, announced Tuesday plans for a new, 5-year blueprint for how the agency will advance antimicrobial stewardship in veterinary settings. The goal, he said, is to cut back on overuse of antimicrobial drugs and fight the increasing threat of resistance.
Current pricing and rebate system encourages high list prices
FDA approved on Monday iobenguane I 131 (Azedra—Progenics Pharmaceuticals) injection for the treatment of rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that are unresectable, have spread beyond the original tumor site, and require systemic anticancer therapy.
FDA on Friday said it "wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA." The agency announced on July 13 a recall of particular batches of valsartan tablets due to an impurity, the chemical N-nitrosodimethylamine (NDMA).
FDA unveiled on Thursday two new voluntary programs, the Quality Metrics Feedback Program and the Quality Metrics Site Visit Program. The programs were developed in response to stakeholder requests for ongoing dialogue about quality metrics, and to give industry ways to engage and inform FDA's use of them in the future.
Follow-up to July 13 recall of valsartan products
FDA has cleared elagolix (Orilissa—AbbVie) for the treatment of moderate to severe pain associated with endometriosis. The drug, which is expected to be available next month, is the first oral gonadotropin-releasing hormone antagonist specifically developed for the treatment of this condition.
Changes encourage innovative approaches to demonstrating safety and effectiveness
FDA on Monday issued a compounding risk alert to warn health care providers, compounders, and patients of the dangers of using the bulk drug substance cesium chloride. Cesium chloride is sometimes used by cancer patients despite never having been proven safe and effective for any use.
FDA approved on Friday ivosidenib (Tibsovo—Agios Pharmaceuticals) tablets for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) who have a particular genetic mutation. The drug is approved for use with an FDA companion diagnostic used to identify specific mutations in the IDH1 gene in patients who have AML.