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.

Over the years, the FDA has received reports of serious and sometimes fatal consequences from intravenous (IV) injection of the liquid contents of oral nimodipine capsules. IV administration of nimodipine meant for oral use can result in death, cardiac arrest, severe decreases in blood pressure and other heart-related complications. In August 2010, the agency reminded health care professionals about the risks of IV administration of nimodipine from oral capsules and in 2006 a Boxed Warning was added to the drug to warn against such use.