Wayne, NJ,- In agreement with the U.S. Food and Drug Administration (FDA), Bayer HealthCare Pharmaceuticals Inc. today announced that it has updated the labels for its drospirenonecontaining combination oral contraceptives (COCs) in the United States.
Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, has installed variable print ink-jet technology from Weiler Labeling Systems (WLS). Incorporated into Sanofi Pasteur’s existing label application systems at its Swiftwater, PA, facility, the WLS system prints a Data Matrix bar code encrypting the necessary information into each label.
AstraZeneca announced that on March 7, the Food and Drug Administration (FDA) denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for Seroquel (quetiapine fumarate) tablets and Seroquel XR (quetiapine fumarate) extended-release tablets.
AstraZeneca said it is evaluating the FDA's decision and reasoning.
Paperboard packaging supplier Chesapeake Pharmaceutical and Healthcare Packaging has installed a new Alprinta 52 web offset press at its Hicksville, NY, facility. The four–color press, which can run materials up to 20.5 in. wide and 40 in. long, will be used to print patient-information leaflets for the healthcare market. It also features UV curing and a non-stop rewinding unit for re-insertion, giving Chesapeake the capacities to run up to 8 colors.
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.
NEW YORK, N.Y. – Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic) for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.
PMP News's sister publication IVD Technology will be hosting a paid Webcast on companion diagnostics on Thursday, November 10. According to Richard Park, editor of IVD Technology, companion diagnostics for personalized medicine is the most important emerging trend in the IVD industry today.
Cosmetic packaging provider Topline Products is working with tube manufacturer Viva Healthcare to market injection-molded polypropylene (PP) tubes with in-mold labeling (IML). The technology, created by Viva Healthcare, offers both aesthetic and environmentally friendly features. “We are now ready for mass production of this tube,” reports Charles Chang, president of Topline Products.
Earlier this year, PMP News held the Webcast, “Understanding Braille Packaging Requirements.” Speaking on current Braille standards around the world were Nosco’s Braille Implementation Advisor, Rachel Greiner, and Director of Quality, Dick Leach. Greiner and Leach examined how pharmaceutical companies can adopt quality standards that adhere to global Braille requirements.