Akorn gets supplemental NDA approval for Inapsine nausea treatment

By Elaine Rigoli

Tampa, Fla., April 24 - Akorn, Inc. announced that it has received a supplemental New Drug Application approval for Inapsine (droperidol) injection to be marketed for the first time since 2001.

Akorn said it expects to launch Inapsine in June.

Inapsine, a tranquilizer used typically as a premedication for anesthesia, as treatment for nausea after anesthesia and for sedation of agitated patients, has been off the market due to safety and compliance concerns.

The Food and Drug Administration added a "black-box" labeling in November 2001 because of reports of fatal cardiac arrhythmias associated with use of the drug.

Akorn issued a "Dear Health Care Professional" letter on Dec. 4, 2001 that described the labeling changes and the added warning about reports of patient deaths associated with use of droperidol at or below the recommended minimum dosage of 2.5 mg.

Akorn recently was awarded the Premier Purchasing Partners, LP contract for Inapsine, effective July 1.

Akorn, located in Buffalo Grove, Ill., manufactures and markets sterile specialty pharmaceuticals.

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