Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

September 2009 Drug Safety Labeling Changes - 36 drugs with changes*

The "Summary Page" provides a listing of drug names and safety labeling sections revised.

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

AndroGel (testosterone gel), Rapamune (sirolimus), Testim (testosterone gel), Cordarone (amiodarone HCl), Flector Patch (diclofenac epolamine), Intelence (etravirine), Kayexalate (sodium polystyrene sulfonate), Lexiva (fosamprenavir calcium), Neoral (cyclosporine capsules, modified), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Pre-Pen (benzylpenicilloyl polylysine), Sustiva (efavirenz), Ultracet (tramadol HCl/acetaminophen), Ultram (tramadol hydrochloride), Voltaren Gel (diclofenac sodium), Zolinza (vorinostat).
Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?