This article is more than 5 years old. Information may no longer be current.

B&L withdraws European marketing application for Retisert implant

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Bausch & Lomb Ireland has formally notified the European Medicines Agency of its decision to withdraw the application for centralized marketing authorization of B&L's Retisert fluocinolone acetonide 590 µg intravitreal implant, the agency announced in a press release.

The Retisert implant was designated as an orphan medicinal product in March 2005. B&L had submitted a marketing authorization application to the European Medicines Agency (EMEA) in September 2006, seeking approval to market the device as a treatment for chronic, noninfectious posterior segment uveitis.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) was reviewing the application at the time of the withdrawal, according to the release.

In its official letter, B&L stated that it based the withdrawal on the CHMP's request for additional information, which B&L could not respond to within the permitted timeframe, the release said.