The Food and Drug Administration is allowing Eisai Co. to sell its European-approved Panretin gel tubes in the U.S., despite an ongoing shortage of the FDA-approved version of the gel.
Panretin is used to treat skin sores in patients with a certain type of AIDS-related cancer. The U.S. is experiencing a shortage of the FDA-approved gel due to manufacturing issues.
While the FDA approved the temporary use of the European version of the drug, the product does contain different prescribing information on its label than the American version. Therefore, a copy of the FDA-approved prescribing information will be distributed with the European version of Panretin.
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