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Bupivacaine granted FDA's orphan drug status


CUPERTINO, Calif. The Food and Drug Administration has granted orphan drug designation for bupivacaine, the active ingredient of Durect’s transdermal patch Eladur, Durect announced Monday.

Unlike other anesthetic patches, which last for up to 12 hours, Eladur will last for three days. The drug is designed to relieve pain associated with post-herpetic neuraligia and herpes zoster infection.

Durect will have exclusive marketing rights for Eladur for seven years if it is the first bupivacaine product the FDA approves for post-herpetic neuraligia.

AstraZeneca markets bupivacaine products under the names Marcaine and Sensorcaine. Sales figures for bupivacaine products were not available from AstraZeneca.

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