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FDA announces plans to pilot end-stage kidney disease technology in new program

REMS Advisor Admin — Thu, 19 Apr 2012 18:23:01 +0000

Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

The FDA selected three from 32 product applications ranging from an artificial kidney to devices that assist kidney function that were submitted in response to a January 2012 request from FDA’s device center.

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FDA approves Omontys to treat anemia in adult patients on dialysis

REMS Advisor Admin — Thu, 19 Apr 2012 18:19:50 +0000

The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).

Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with CKD. Omontys is administered as a once-a-month injection.

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FDA approves imaging drug Amyvid

REMS Advisor Admin — Tue, 10 Apr 2012 18:23:16 +0000

Estimates brain amyloid plaque content in patients with cognitive declineThe U.S. Food and Drug Administration today approved Amyvid (Florbetapir F 18 Injection) a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. Cognitive decline refers to a condition where the ability to think and form clear, rational thoughts and decisions has decreased. It can cause an individual to lose touch with reality, oneself, other people, and external events and surroundings

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FDA approves additional blood test for viruses linked to leukemia, neurologic diseases

REMS Advisor Admin — Tue, 27 Mar 2012 18:20:22 +0000

Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved today by the Food and Drug Administration.

Avioq HTLV-I/II Microelisa System, is the only test now available that can be used to both screen the blood supply for antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Human T-Lymphotropic Virus Type II (HTLV-II), and help diagnose infection with these viruses.

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FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease

REMS Advisor Admin — Thu, 22 Mar 2012 18:15:49 +0000

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.

GERD is a condition in which food or liquid in the stomach flows back into the esophagus. This can irritate the esophagus, causing heartburn and other symptoms.

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FDA approves first Boniva generics to treat or prevent osteoporosis

REMS Advisor Admin — Mon, 19 Mar 2012 17:04:45 +0000

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.

The most common type of bone disease, osteoporosis, is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures of the hip, spine, and wrist. Ibandronate is in a class of medications called bisphosphonates that help increase bone mass and reduce the chance of having a spinal fracture.

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FDA approves first cell-based product to treat oral mucogingival conditions in adults

REMS Advisor Admin — Fri, 09 Mar 2012 20:57:14 +0000

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.

GINTUIT is used as part of a surgical procedure to treat mucogingival conditions. The treatment regimen is a single application of GINTUIT over a surgically created vascular wound bed in the mouth.

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FDA approves first generic Lexapro to treat depression and anxiety disorder

REMS Advisor Admin — Fri, 09 Mar 2012 18:02:56 +0000

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.

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FDA approves Surfaxin to prevent breathing disorder in premature infants

REMS Advisor Admin — Tue, 06 Mar 2012 20:55:18 +0000

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.

The lungs of premature infants are not able to make enough surfactant, a liquid that coats the inside of the lungs and helps to keep them open. Without enough surfactant, the lungs collapse and the infant has difficulty breathing. Most babies who develop RDS show signs of breathing problems and a lack of oxygen at birth or within the first few hours after birth.

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FDA approves two new pancreatic enzyme products to aid food digestion

REMS Advisor Admin — Thu, 01 Mar 2012 20:54:04 +0000

Approvals to help ensure adequate supply of these medications

Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.

Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious genetic disorder affecting the lungs and other organs, or other conditions who cannot digest food normally because their pancreas does not make enough pancreatic enzymes.

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