Labeling

Bayer Updates Labels on Combination Oral Contraceptives

The labels of combination oral contraceptives with drospirenone indicate the drugs may bear a higher risk of venous thromboembolism.

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.

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Weiler Labeling Systems Supports Sanofi Pasteur's Data Matrix Printing

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.

Citizen Petitions for Warning on AstraZeneca Label Denied

The FDA has turned down a request from individuals requesting the agency withhold approval of a label that omits hyperglycemia warning language.

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.

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Chesapeake Installs New Four-Color Press

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.

FDA Announces Cholesterol Drug Label Changes

The agency has announced changes to the labeling on several products, related to improving patient safety.

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.

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Pfizer Issues Recall for Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets

The company has voluntarily recalled 14 lots of the drugs after determining some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence.

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.

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The Latest in Bags & Pouches

Plasma Bag Label

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Webcast on Companion Diagnostics to Include Labeling Discussion

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.

In-Mold Labeling for Tubes

Two companies unite to introduce injection-molded tubes with in-mold-labeling.

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.

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Webcast Wrap Up: Understanding Braille Packaging Requirements

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.

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