FDA News Briefs for Monday, March 5, 2018March 5, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Safety Alert: Compounded Drugs by Cantrell Drug Company
The FDA is alerting health care professionals and patients not to use drug products produced by Cantrell Drug Company of Little Rock, Arkansas, including opioid products and other drugs intended for sterile injection that were produced by the company and distributed nationwide. The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility assurance, that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death. More Information.
FDA Advisory Committee to Review Blincyto for Additional ALL Indication
The Oncologic Drugs Advisory Committee will meet on March 7, 2018, to review a supplemental biologics license application for Blincyto (blinatumomab; Amgen Inc.) for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia (ALL). Blincyto is currently FDA approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children. More Information.
FDA Advisory Committee to Review Xeljanz for Treatment of Ulcerative Colitis
The Gastrointestinal Drugs Advisory Committee will meet on March 8, 2018, to review a supplemental new drug application for Xeljanz (tofacitinib; Pfizer Inc.) for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy. Xeljanz is currently FDA approved for treatment of rheumatoid arthritis and psoriatic arthritis. More Information.
FDA Advisory Committee to Review Eversense CGM
The FDA Clinical Chemistry and Clinical Toxicology Devices Panel is scheduled to review the premarket approval application (PMA) for the Eversense continuous glucose monitoring system (Senseonics) on March 29, 2018. The Eversense CGM is an investigational continuous glucose monitor with implantable sensor for management of diabetes mellitus in adult patients who use insulin. The Eversense CGM System consists of 3 components: an implantable cylindrical glucose sensor, a wearable smart transmitter, and a handheld device running a mobile medical application. The transmitter is worn over the implanted sensor for continuous readout of glucose data, but can be removed and replaced without the need for sensor replacement. The Eversense CGM system works in tandem with a mobile application that allows for the real-time display of interstitial glucose readings. The transmitter stores glucose data and provides the patient with on-body vibrations for notification of hypoglycemia and hyperglycemia. More Information.