The Food and Drug Administration today approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.
Category Archives: Drug Safety Information Podcasts
FDA approves first Boniva generics to treat or prevent osteoporosis
The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
FDA proposes lower risk classification for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA proposes lower risk classification, guidance for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis. This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA approves first generic Lexapro to treat depression and anxiety disorder
The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.
Depression is characterized by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime.
La FDA aprueba nuevos implantes de seno rellenos de gel de silicona
La Administración de Alimentos y Drogas de los Estados Unidos (FDA) aprobó hoy los implantes de seno rellenos de gel de silicona fabricados por Sientra Inc. para aumentar el tamaño del seno (aumentación) en las mujeres por lo menos 22 años de edad y para reconstruir el tejido de los senos (reconstrucción) en las mujeres de cualquier edad.
FDA approves new silicone gel-filled breast implant
Today, the U.S. Food and Drug Administration approved a silicone gel-filled breast implant manufactured by Sientra Inc. to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.
FDA approves first cell-based product to treat oral mucogingival conditions in adults
The Food and Drug Administration today approved GINTUIT, the first cell-based product made from allogeneic human cells (from a donor unrelated to the patient) and bovine collagen. GINTUIT is indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
FDA Commissioner Margaret A. Hamburg’s Statement on the Surgeon General’s Report
Tobacco use is the leading cause of preventable death in our nation. And until we dramatically decrease the access and appeal of tobacco products to youth, it will remain one of America’s most pressing health problems. Today’s ground-breaking report by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to keep kids off tobacco.
FDA approves Surfaxin to prevent breathing disorder in premature infants
The U.S. Food and Drug Administration today approved Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants.