FDA Approves Arbor’s Nymalize For Treating Certain Type of Hemorrhage

Arbor Pharmaceuticals Inc. May 13 announced that the Food and Drug Administration has approved Nymalize (nimodipine) oral solution for the improvement of neurological outcome in adult patients with subarachnoid hemorrhage.

Before the approval, nimodipine was only available in gel capsule form, the company said. The product had been granted orphan drug designation, which provides seven years of market exclusivity.

Nymalize is Arbor’s first new drug application approved by FDA, according to the company, which is based in Atlanta.

Safety.

In 2010, FDA issued a drug safety communication to health care professionals regarding administration errors with intravenous nimodipine (8 PLIR 1029, 8/6/10