Antidepressant DTC Ads Must Disclose New Risk Information Within 30 Days
This article was originally published in The Pink Sheet Daily
Executive Summary
Antidepressant manufacturers have 30 days to bring their direct-to consumer ads into compliance following FDA's approval of a "black box" class warning
You may also be interested in...
FDA Approves Antidepressant "Black Box" Class Labeling
The revised labeling should be available on manufacturers' web pages within two weeks and on all products within 30 days, FDA says. Medication Guides should be available to pharmacists by Jan. 31, the agency says.
Antidepressant “Black Box” Warning For Pediatric Suicidality Risk Recommended
“Black box” warning would encourage discussion of risks and benefits of antidepressant therapy in children by physicians, FDA advisory committee members say. Warning likely to affect direct-to-consumer advertising, FDA notes. Committee members recommend class warning for all antidepressants, including new products.
U.S. Patents Could Limit President's AIDS Drug Assistance Plan, GAO Says
The U.S. Global AIDS Coordinator's Office suggests it will use its authority to purchase an FDA-approved generic antiretroviral product for which permission could not be obtained from the patent holder. FDA grants tentative approval to a South African firm for a generic co-packaged version of Combivir and Viramune.