This section of the newsletter discusses recent drug approvals from U.S. Food and Drug Administration (USFDA) for various serious diseases. The section outlines the role of new drugs in the treatment of serious diseases such as cancer, heart disease and from tobacco products. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market1
The U.S. Food and Drug Administration has announced that it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). Ranitidine belongs to a group of drugs called histamine-2 blockers. It works by reducing the amount of acid your stomach produces. Ranitidine is used to treat and prevent ulcers in the stomach and intestines.
FDA Approves Additional Treatment for Adults and Adolescents with Hemophilia A or B with Inhibitors2
The U.S. Food and Drug Administration has approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies). Sevenfact contains an active ingredient expressed in genetically engineered rabbits. Hemophilia A or B is a congenital bleeding disorder caused by a dysfunction or deficiency of Coagulation Factor (F) VIII or IX, respectively. People with hemophilia may bleed for a longer time than others after injury or surgery. They may also have spontaneous bleeding in muscles, joints and organs, which may be life-threatening. The FDA granted approval of Sevenfact to Laboratoire Francais du Fractionnement et des Biotechnologies S.A.
FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic3
As part of the U.S. Food and Drug Administration's ongoing commitment to fight the COVID-19 pandemic, the agency issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components. The COVID-19 pandemic has caused unprecedented challenges to the U.S. blood supply. Donor centers have experienced a dramatic reduction in donations due to the implementation of social distancing and the cancellation of blood drives.
Footnotes
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
