FDA approves Arbor Pharma's Nymalize for use in certain brain hemorrhage patients
Privately-held US firm Arbor Pharmaceuticals says that the US Food and Drug Administration has approved its New Drug Application for Nymalize (nimodipine) oral solution, marking the first NDA approval for the company.
Nymalize was previously granted Orphan designation which provides seven years of market exclusivity. Nymalize is the first and only nimodipine oral solution indicated for the improvement of neurological outcome in adult patients with subarachnoid hemorrhage (SAH). Arbor said it will launch Nymalize in the next few months.
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