Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize( nimodipine) oral solution

14 05 2013

New Drug Approvals

NIMODIPINE

Arbor Pharmaceuticals Announces FDA Approval of Nymalize

 May 13, 2013 – Atlanta, GA – Arbor Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Nymalize (nimodipine) oral solution. 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).
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Prior to the approval of Nymalize, nimodipine was only available in gel capsule form. Since the product is commonly administered to patients through a nasogastric tube healthcare providers would extract the product from the gel capsule with a syringe. This has resulted in accidental administrations of nimodipine intravenously instead of via the intended enteral (oral) syringe.

In 2010, the FDA issued a “drug safety communication” to healthcare professionals titled “Nimodipine Oral Capsules: Medication Errors…

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