Drugs

REMS Updates Announced

FDA says the following updates have been made to the REMS@FDA approved Risk Evaluation and Mitigation Strategies (REMS) Web site. Changes include:
Sanofi Aventis Multaq REMS released 2/12; PF Prism Xeljanz REMS released 2/8; Isotretinoin iPLEDGE shared system REMS modified 2/4 to increase awareness and compliance with the appropriate classification of female patients of reproductive potential on the iPLEDGE Web site; Novo Nordisk Saxenda REMS modified 2/1 to modify the REMS document for consistency with presentation of current consumer/product Web sites; Prometheus Labs Lotronex REMS and alosetron REMS modified 1/7 to modify the REMS goal, remove the Medication Guide as a REMS element, and modify the elements to assure safe use; Transmuscosal immediate-release fentanyl shared system REMS modified 12/21/15 to revise the Medication Guide to include the new strength of 300 mcg per spray; and Alkermes Vivitrol REMS modified 12/8/15 to change the appended materials including a poster and a Dear Healthcare Provider letter.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome