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Related terms: Orthostatic Hypotension

Flamel Technologies Announces FDA Approval of Vazculep

Posted 3 Jul 2014 by Drugs.com

LYON, FRANCE--(Marketwired - Jun 30, 2014) - Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for Vazculep (phenylephrine hydrochloride). Vazculep Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Flamel expects to launch Vazculep in the next few months in 1 mL single use vials, and 5 mL and 10 mL pharmacy bulk package vials. The drug strength is the same in all vials at 10 mg/mL. Phenylephrine hydrochloride is used in operating rooms and is injected intravenously either as a bolus or in a dilute solution as a continuous infusion. "We are extremely pleased to receive NDA approval for Vazculep from the FDA," said Mike Anderson, Chief Executive Officer ... Read more

Related support groups: Phenylephrine, Hypotension

FDA Approves Northera to treat Neurogenic Orthostatic Hypotension

Posted 20 Feb 2014 by Drugs.com

February 18, 2014 – The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue and fainting when a person stands. “People with neurogenic orthostatic hypotension are often severely limited in their ability to perform routine daily activities that require walking or standing,” said Norman Stockbridge, M.D., Ph.D, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “There are limited treatment options for people with NOH and we are committed to helping make safe and effective treatments ... Read more

Related support groups: Hypotension, Orthostatic Hypotension

Study: Low Blood Pressure May Weaken Brains of Some Heart Patients

Posted 10 Jun 2013 by Drugs.com

MONDAY, June 10 – People suffering from cardiovascular disease who have lower-than-normal blood pressure may face a higher risk of brain atrophy – the death of brain cells or connections between brain cells, Dutch researchers report. Such brain atrophy can lead to Alzheimer's disease or dementia in these patients. In contrast, similar patients with high blood pressure can slow brain atrophy by lowering their blood pressure, the researchers added. Blood pressure is measured using two readings. The top number, called systolic pressure, gauges the pressure of blood moving through arteries. The bottom number, called diastolic pressure, measures the pressure in the arteries between heartbeats. Normal blood pressure for adults is less than 120/80, according to the U.S. National Heart, Lung, and Blood Institute. For the study, 70 to 90 was considered normal diastolic blood pressure, while ... Read more

Related support groups: Hypotension

Lightheadedness Upon Standing Could Signal Heart Risk

Posted 19 Mar 2012 by Drugs.com

MONDAY, March 19 – If your blood pressure drops suddenly when you stand up, leaving you feeling lightheaded or woozy, you may be at greater risk for developing heart failure, a new study suggests. This condition is known as orthostatic hypotension. According to the study, people with orthostatic hypotension were 54 percent more likely to develop heart failure than their counterparts who did not develop low blood pressure upon standing. This risk was reduced to 34 percent when the researchers teased out those who also had high blood pressure. "Multiple risk factors can increase a person's risk for developing heart failure, including high blood pressure, coronary heart disease and diabetes," explained study author Dr. Christine DeLong Jones, a preventive medicine resident at the University of North Carolina at Chapel Hill. "Orthostatic hypotension may also increase this risk." Heart ... Read more

Related support groups: Heart Failure, Congestive Heart Failure, Hypotension

Drug in Limbo, Catch-22 for FDA

Posted 26 Sep 2011 by Drugs.com

From Philadelphia Inquirer (PA) (September 25, 2011) Sept. 25--The normal tug-of-war between a pharmaceutical company and the U.S. Food and Drug Administration over approval for a drug has been turned on its side with midodrine, a medicine that helps about 100,000 patients a year avoid the potential dangers of low blood pressure. Shire Pharmaceuticals Inc., with U.S. headquarters in Wayne, no longer makes the drug, but it wants the FDA to give final approval of midodrine to lift a regulatory cloud. Barring that, it wants the FDA to approve Shire's plan for new trials or hold a hearing that might kill the drug. Though it has been on the market for 15 years under a temporary approval, midodrine never passed its final clinical trials. Now, the FDA is in a bind no matter how it acts, including doing nothing. "It is a Catch-22," said cardiologist John Harold of the Cedars-Sinai Heart ... Read more

Related support groups: Hypotension, Midodrine, ProAmatine, Orvaten

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phenylephrine, ephedrine, midodrine, norepinephrine, ProAmatine, Levophed, Nasop12, Northera, Vazculep, view more... Despec-SF, Phenyl-T, Lusonal, Orvaten, droxidopa, Gilchew IR, Nasop, Ricobid-D, Levophed Bitartrate