Lilly announces new color labeling system for insulin products
INDIANAPOLIS People prescribing, dispensing and using insulin for diabetes will be able to accurately identify the type of insulin using a color-coding system introduced Monday.
Eli Lilly announced the introduction of the system for U-100 insulin products marketed in the United States, including vials, pens and individual packaging for Humalog and Humulin.
The system, also used for Humulin and Humalog in Europe, follows the introduction of bar coding of packaging and insulin vials that Lilly instituted in the United States in 2004.
“Insulin is a powerful medicine that has an 85-year track record of efficacy and safety when administered and used properly,” Lilly associate medical director Sherry Martin said. “But if insulin is administered improperly, patients could be put at serious risk of medical injury because blood sugar levels may drop too low.”
Colors indicate insulin family and insulin type and will include burgundy for the Humalog family, blue for the Humulin family and yellow for regular insulin; a blue-yellow combination would indicate Humulin-R.
FDA launches new Web page to provide safety information on prescription drugs
WASHINGTON The Food and Drug Administration announced Wednesday that it had launched a Web page to provide consumers and healthcare professionals with a single source of safety information about prescription drugs.
The page, www.fda.gov/cder/drugsafety.htm, provides links to information in categories such as drug labeling, drugs with risk evaluation and mitigation strategies, regulations and guidance documents and warning letters, import alerts, recalls, market withdrawals and safety alerts.
“By placing Web links to these up-to-date resources on a single page, we’re helping consumers and healthcare professionals find drug safety information faster and easier,” said Dr. Paul Seligman, associate director of safety policy and communication in the FDA’s Center for Drug Evaluation and Research. “This type of communication is aimed at helping consumers and healthcare professionals make well-informed decisions about medication use.”
FDA approves generic version of Epivir
WASHINGTON The Food and Drug Administration has granted tentative approval to Indian drug maker Macleods Pharmaceuticals’ generic version of GlaxoSmithKline’s HIV drug Epivir (lamivudine), FDA records show.
The drug would be available as 150 mg and 300 mg tablets, but cannot be marketed in the United States because of patent protection.
GSK’s patent for lamivudine will expire in 2010. Epivir had sales of $246.85 million in 2007, according to GSK financial records.