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Complete Response Letter for Northera (Chelsea Therapeutics) for Neurogenic Orthostatic Hypotension

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Last updated:29th Mar 2012

Published:29th Mar 2012

Source: Pharmawand

The FDA has issued a Complete Response Letter regarding the new drug application for Northera (droxidopa) from Chelsea Therapeutics for the treatment of Symptomatic Neurogenic Orthostatic Hypotension in patients with primary autonomic failure. The FDA requests an additional study for efficacy and durability of effect over 2-3 months. Chelsea believes an ongoing Study 306 may meet this criteria.

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