FDA Allows Use of E.U.-Approved Topical Drug Due to Shortage

The FDA stressed that clinicians will still need to refer to the U.S.-approved package information
The FDA stressed that clinicians will still need to refer to the U.S.-approved package information

Due to a shortage of U.S.-approved Panretin gel (alitretinoin 0.1%; Eisai), the Food and Drug Administration (FDA) has announced they are allowing the sale of the E.U.-approved version of the gel, accompanied with a copy of the U.S.-approved prescribing information.

The shortage of the U.S.-approved gel is the result of a tube manufacturing issue. The FDA has confirmed that the E.U. gel meets their manufacturing release specifications, however, as the E.U. and U.S. labels differ, they stress that clinicians should refer to the U.S.-approved package insert information only. 

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Panretin gel, retinoid, is approved for the topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma (KS), but is not indicated when systemic anti-KS therapy is required. 

Eisai is working closely with the FDA to address the manufacturing issues for the U.S.-approved Panretin gel product. Adverse events experienced with the use of Panretin should be reported to the FDA's Medwatch Adverse Event Reporting Program

For more information visit FDA.gov.