Labeling

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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New Virtual Conference Focused on Track & Trace Solutions for the Pharma Sector

Now in our archives is our exclusive virtual conference event that examines one of the key issues facing the Pharma and BioPharma supply chain, counterfeit drugs. Titled ‘Pharmaceutical Track & Trace and Authentication: The Fight against Fake Drugs’, the event is presented by UBM brands Pharmaceutical & Medical Packaging News, Tracking & Tracing Pharmaceutical Products, InnoPack, and Pharmapack in association with CPhI Conferences. The online format features two supplier webinars, two “exhibition halls” and a lineup of featured speakers.

Heidelberg Acquires CSAT

Heidelberger Druckmaschinen AG (Heidelberg) has acquired CSAT GmbH, a provider of industrial digital printing systems that can be integrated into production lines. This purchase enables Heidelberg to expand its digital print portfolio as well as add technology and expertise in the areas of drop-on-demand inkjet (DoD) and electrophotography.

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