Drug shortage spurs FDA to allow use of topical gel approved in Europe

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.

More articles on suppy chain:

Pfizer CEO responds to Trump's threats against pharma: 'We need to raise prices'
Short seller predicts Lannett will be first drugmaker to go bankrupt amid price scrutiny
Washington, D.C.-area hospitals desperate for blood donations ahead of inauguration

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars