丹麦灵北制药:FDA正式批准公司神经源性体位性低血压新药droxidopa

摘要:  September 2, 2014Lundbeck announces availability of NORTHERA™ in the U.S.Northera™ (droxidopa) is approved by the FDA for treatment of Neurogenic Orthostatic Hypotension (NOH), a disorder ...


September 2, 2014

Lundbeck announces availability of NORTHERA™ in the U.S.

Northera™ (droxidopa) is approved by the FDA for treatment of Neurogenic Orthostatic Hypotension (NOH), a disorder caused by an underlying neurologic disease (e.g., Parkinson's disease, multiple system atrophy or pure autonomic failure)

 

Northera™ (droxidopa) is approved by the FDA for treatment of Neurogenic Orthostatic Hypotension (NOH), a disorder caused by an underlying neurologic disease (e.g., Parkinson's disease, multiple system atrophy or pure autonomic failure)


Valby, 2014-09-02 16:00 CEST (GLOBE NEWSWIRE) -- H. Lundbeck A/S (Lundbeck) announced today that NORTHERA™ (droxidopa) capsules for oral use are now available through its U.S. subsidiary Lundbeck LLC for healthcare providers to prescribe in the United States. NORTHERA™, a norepinephrine prodrug, was recently approved by the U.S. Food and Drug Administration, and is now available across the United States through a specialty pharmacy.2 NORTHERA™ is only approved for the U.S.NORTHERA™ is approved for the treatment of orthostatic dizziness, lightheadedness or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy3.

Symptomatic NOH is a rare autonomic nervous system disorder associated with failure to release adequate amounts of norepinephrine upon standing.4 NOH is caused by an underlying autonomic neurologic disorder, such as Parkinson's disease, multiple system atrophy, or pure autonomic failure.1 Norepinephrine deficiency may result in an inability for a person to maintain adequate blood pressure and blood flow to the brain upon standing, resulting in dizziness, lightheadedness, and the "feeling that you are about to black out."1,3,4

 

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