Avandia REMS Limits Access To Mail Order Pharmacies Beginning In November
This article was originally published in The Pink Sheet Daily
The Risk Evaluation and Mitigation Strategy for all rosiglitazone-containing products also requires prescriber, pharmacy and patient enrollment as well as special certification for distributors.
You may also be interested in...
FDA Polled Review Staff On Avandia REMS Changes
Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.
FDA Replaces Avandia REMS Distribution Restrictions With Prescriber Training
Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.
Avandia RECORD Study Re-Analysis To Get FDA Committee Scrutiny
Two FDA panels will jointly review an independent “re-adjudication” of GlaxoSmithKline’s RECORD study of Avandia’s cardiovascular risk; 12 of 33 panel members voted to withdraw the drug when they considered the RECORD data in 2010.