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Once a year treatment for osteoporosis now available in the U.S.

A once-a-year treatment for the bone-thinning disease osteoporosis has been given approval by the Food and Drug Administration (FDA) in the United States.

20 Aug 2007

FDA approves updated labeling for Warfarin (Coumadin)

The U.S. Food and Drug Administration has announced the approval of updated labeling for the widely used blood-thinning drug, Coumadin, to explain that people's genetic makeup may influence how they respond to the drug.

17 Aug 2007

Baxter awarded major contract for flu vaccine in the event of a pandemic

Baxter International Inc. has announced that Baxter's European subsidiary in the United Kingdom has entered into an advanced supply agreement with the Department of Health that contains an option to purchase pandemic influenza vaccine in the event the World Health Organization (WHO) declares a pandemic.

From Baxter International Inc. 17 Aug 2007

Strengthened warnings on some type 2 diabetes drugs

The U.S. Food and Drug Administration has announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood.

16 Aug 2007

Rotarix accepted for review by FDA

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for Rotarix, an oral candidate vaccine for infants to prevent rotavirus gastroenteritis.

16 Aug 2007

FDA tells drug giant to come clean about Alzheimer's drug

The Food and Drug Administration (FDA) in the U.S. has warned a major drug company about misleading the medical profession over a drug for dementia.

15 Aug 2007

Roche files investigational new drug application for second Genmab antibody

Genmab A/S has announced that its partner Roche has filed an Investigational New Drug application (IND) with the US Food and Drug Administration for a Genmab antibody developed under the companies' collaboration.

13 Aug 2007

Mylan receives FDA approval for Verapamil Hydrochloride capsules

Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Verapamil Hydrochloride (HCl) Extended-release (ER) Capsules (PM), 100 mg, 200 mg and 300 mg.

13 Aug 2007

LifeCycle Pharma and Sciele Pharma announce FDA approval of new formulation of Fenofibrate

LifeCycle Pharma and Sciele Pharma announce FDA approval of fenofibrate in 120 mg. and 40 mg. dosage strengths. Sciele Pharma expects U.S. market launch by the end of 2007.

13 Aug 2007

Diovan (valsartan) granted pediatric exclusivity by FDA

Diovan (valsartan) has been granted pediatric exclusivity by the US Food and Drug Administration (FDA) based on studies conducted in children with high blood pressure.

13 Aug 2007

Special nasal cream will bust deadly superbugs

A special cream enriched with bacteria-busting viruses has been developed by scientists in Britain and it could eradicate deadly superbugs such as MRSA from hospitals.

13 Aug 2007

Actavis receives FDA OK for generic Inderal capsules

Actavis Group has announced that it has received approval from the U.S. Food & Drug Administration to market Propranolol Hydrochloride extended-release capsules. Distribution of the product will commence immediately.

13 Aug 2007

Sanofi pasteur ships doses of Fluzone influenza vaccine for the 2007-2008 season

Sanofi pasteur, the vaccines division of the sanofi-aventis Group, has begun shipment of influenza vaccine (Fluzone, Influenza Virus Vaccine) in the United States for the 2007-2008 season.

13 Aug 2007

FDA taking no chances when it comes to drug safety

These days the U.S. Food and Drug Administration (FDA) is taking no chances when it comes to the safety of new drugs.

13 Aug 2007

Biomira and Merck KGaA sign agreements on Stimuvax

Biomira Inc. has announced the signing of amended and restated collaboration and supply agreements related to Stimuvax with Merck KGaA of Darmstadt, Germany.

12 Aug 2007

90 percent of seniors now have prescription drug coverage

More than 90 percent of Americans age 65 and older now have prescription drug coverage, compared to more than 75 percent who were covered in 2004, according to a University of Michigan analysis. And poor seniors are as likely to have coverage as the rich.

12 Aug 2007

GSK receives FDA 'not approvable letter' for Advair for COPD

GlaxoSmithKline has announced that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).

9 Aug 2007