USFDA

The U.S. Food and Drug Administration cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

The U.S. Food and Drug Administration authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the first such controller that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery. This FDA authorization paves the way for iCGMs and ACE pumps to be used with an interoperable automated glycemic controller as a complete automated insulin dosing (AID) system. AID systems typically consist of a pump, CGM and software to control the system of compatible devices.

The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO.

The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards.

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of acute GvHD, a potentially life-threatening medical complication that can impact patients receiving such transplants for the treatment of certain genetic diseases and hematologic cancers.

This guidance provides FDA’s current thinking on drug master files (DMFs), which are  submissions to FDA that may be used to provide confidential, detailed information about  facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types of information as well (e.g., toxicology  information, shared system REMS (risk evaluation and mitigation strategy).

As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, the U.S. Food and Drug Administration granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

The U.S. Food and Drug Administration approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults.

A seizure is a usually short episode of abnormal electrical activity in the brain. Seizures can cause uncontrolled movements,  abnormal thinking or behavior, and abnormal sensations. Movements can be violent, and changes in consciousness can occur. Seizures occur when clusters of nerve cells (neurons) in the brain undergo uncontrolled activation. A partial-onset seizure begins in a limited area of the brain.

U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older.

Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, and microorganisms such as bacteria or yeast, and developed using advanced science. They are usually more complex than other drugs and are particularly critical in the treatment of cancer and autoimmune conditions, such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.