Dr. Reddy’s Gets FDA Advertising Letter, But Its Response Is Far From Generic

09 Jan 2012

• By Martin Berman-Gorvine

Despite changes to the website, the boxed warning about the risk of epidural or spinal hematomas for patients taking generic fondaparinux still receives little emphasis on a Dr. Reddy’s promotional page.

Although Dr. Reddy's Laboratories Ltd. has changed a website promoting its generic version of GlaxoSmithKline Inc.’s acute pulmonary embolism drug Arixtra (fondaparinux) apparently in response to an FDA “notice of violation” letter, the changes may not address the agency’s concerns.

The Dec. 22 letter from FDA's Office of Prescription Drug Promotion critiqued the old version of...