Labeling

Amneal Builds on Customer Input to Upgrade Generic Metformin Labeling

The company has implemented formulation and labeling changes to help increase patient satisfaction and dispensing accuracy.

Amneal Pharmaceuticals, LLC today announced significant formulation and labeling changes to its generic Metformin products, offering substantial improvements in these medications for both pharmacists and their patients.

Your rating: None Average: 5 (2 votes)

Johnson & Johnson Subsidiary Loses Drug-labeling Suit

The state of Arkansas won the ruling in its suit alleging the antipsychotic Risperdal included insufficient risk information in inserts and labels.

LITTLE ROCK, Arkansas — A Johnson & Johnson subsidiary downplayed and hid risks associated with the antipsychotic drug Risperdal, a jury determined Tuesday in Arkansas' billion-dollar lawsuit against Janssen Pharmaceuticals Inc.

Attorney General Dustin McDaniel's office is seeking fines of at least $1.2 billion for the 250,000 Risperdal prescriptions a state health coverage program paid over more than three years. The penalty will be decided Wednesday.

Your rating: None Average: 4 (1 vote)

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.

No votes yet

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.

No votes yet

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.

No votes yet

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.

No votes yet

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.

No votes yet

The Latest in Bags & Pouches

Plasma Bag Label

No votes yet
Syndicate content