FDA approves generic OTC allergy medication
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of an OTC allergy drug, FDA records show.
The agency approved Anmeal Pharmaceuticals’ cetirizine hydrochloride syrup in the 5 mg-per-5 milliliter strength.
The drug is a generic version of Johnson & Johnson’s Zyrtec. Amneal is the 10th company to gain FDA approval for a generic version of the drug. J&J switched Zyrtec from a prescription to an OTC drug last year.
New research finds link between antioxidants, increased diabetes risk
ST. LOUIS A new report in the Oct. 7 issue of Cell Metabolism, a Cell Press publication, found that low levels of free radicals – which commonly are perceived as damaging to a body and the reason behind the consumption of antioxidant vitamins – might actually prevent diabetes by improving the ability to respond to insulin signals.
“Our studies indicate that ‘physiological’ low levels of [free radicals] may promote the insulin response and attenuate insulin resistance early in the progression of Type 2 diabetes, prior to overt obesity and hyperglycemia,” stated Tony Tiganis of Monash University in Australia.
Tiganis said whether antioxidants ultimately are good for people probably will depend on their state of health or disease. “In the case of early Type 2 diabetes and the development of insulin resistance, our studies suggest that antioxidants would be bad for you,” he said.
Under some conditions, treatments designed to selectively increase ROS in muscle – if they can be devised – might even help, he said.
Phadia announces launch of celiac disease tests
UPPSALA, Sweden Phadia on Thursday announced the launch of two new assays to support the accurate diagnosis of celiac disease.
“Our launch this month of EliA Gliadin IgA and EliA Gliadin IgG will offer physicians who suspect a possible case of celiac disease antibody tests with the lowest number of false positive results,” stated Stefan Eschbach, general manager of autoimmunity, Phadia. “This means avoiding putting patients through unnecessary biopsies.”
Celiac disease is a life-long condition in which ingestion of “gluten”, the water insoluble wheat-gliadin and the prolamins in rye and barley, leads to chronic inflammation and damage of the lining of the small intestine.
Approximately 1-out-of-every-250 people may have celiac disease, however, only 1-out-of-10 people with the disease may be actually be diagnosed, Eschbach noted. There may be as many 5 million worldwide with celiac disease.
A Mayo Clinic study published in last month’s issue of Gastroenterology reported that celiac disease is four times more common today than it was 50 years ago. Another key finding: Individuals who don’t realize they suffer from celiac disease (and therefore never received treatment for it) were four times more likely to have died during the study’s 45 years of monitoring versus individuals not affected by celiac disease.