The FDA is allowing the sale of EU-approved Panretin gel (alitretinoin 0.1%) tubes in the United States due to a shortage of the US-approved gel as a result of a manufacturing issue, officials with Eisai announced in a press release that was shared on the FDA’s website.
The US FDA-approved product is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma.
Although the EU-approved Panretin gel meets manufacturing release specifications required by the FDA, the EU-approved product provides different prescribing information on its label than the US gel. For this reason, a copy of the FDA-approved prescribing information will be distributed with the EU-approved products, and providers are urged to refer to the US-approved package information for use.
Eisai is working closely with the FDA to address the manufacturing issues for the US-approved Panretin product. Providers are encouraged to report adverse effects of the drug to the FDA’s Medwatch Adverse Event Reporting Program.