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 Label Articles

FDA proposes Rx label revisions for moms

Stephen McGuire May 29, 2008

The FDA on Wednesday announced it is proposing revisions to physician labeling for Rx drugs to include more info about their use by pregnant and/or breast-feeding mothers.
 

King reduces workforce by 20%, cuts mostly sales jobs

Stephen McGuire October 22, 2007

King Pharmaceuticals will cut 20% of its 2,600 employee workforce after a federal appeals court judge ruled against a patent extension on the company's blood pressure treatment Altace.
 

Amgen seeks to ease investor concerns as staff cuts loom

Marc Iskowitz August 21, 2007

With reimbursement limits the latest threat to its anemia franchise, Amgen moved to shore up investor confidence yesterday.
 

New approval for drug gives Novartis excuse to up promotion

August 20, 2007

The newest indication for Reclast -- postmenopausal osteoporosis -- ups its market potential considerably, analysts said.
 

Warfarin label change advises on genetic factors

Matthew Arnold August 16, 2007

FDA rang in the era of personalized medicine with a labeling change on blood thinner warfarin cautioning that patients with either of two genetic variations might respond differently to the drug, which is sold by BMS under the Coumadin brand.
 

Timing of FDA notice on diabetes meds leads to confusion

Marc Iskowitz August 15, 2007

Yesterdays FDA notice of black-box warnings for GlaxoSmithKlines Avandia, and drugs like it, for congestive heart failure came as a surprise to many.
 

Avoiding the DDMAC letter: Advice from a Pfizer counselor

Marc Iskowitz August 15, 2007

As the FDA keeps up the pressure on marketers for making unsubstantiated claims in their professional promotions, a Pfizer legal expert says companies may be able to avoid such notices by supporting all advertising claims with substantial evidence.
 

Panel votes to keep Avandia on the market with tougher label

Marc Iskowitz July 31, 2007

Federal advisors recommended keeping GlaxoSmithKlines embattled type 2 diabetes drug Avandia on the market but said its label should include strict warnings on use.
 

Avandia meeting could be rough one for GSK

Marc Iskowitz July 27, 2007

An advisory group is set to meet Monday to discuss the cardiovascular safety of GlaxoSmithKline’s type 2 diabetes drug Avandia, and the drug may be in for a rough time.
 

New indication could see Pfizer expand Lyrica ads

Marc Iskowitz June 25, 2007

Pfizers ability to reach what may be an untapped population of people suffering from fibromyalgia got a boost last week when Lyrica became the first FDA-approved therapy for the condition.