Article

Drug Shortage Prompts FDA to Allow Use of EU-Approved Product

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.

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.

Related Videos
Happy elderly patient with medical health checkup with cardiologist or geriatric doctor. Senior old aging woman with coronary artery heart disease or cardiac illness check-up in clinic - Image credit: Chinnapong | stock.adobe.com
Pharmacist and patient in a retail/community pharmacy setting -- Image credit: Zamrznuti tonovi | stock.adobe.com