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Daiichi Sankyo, Lilly submit NDA for investigational antiplatelet drug, Prasugrelin U.S.

Daiichi Sankyo Company, Limited and Eli Lilly and Company have announced that on Wednesday, Dec. 26, 2007, they submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA).

7 Jan 2008

New flu vaccine protects against all strains including bird flu

A new flu vaccine which protects against all strains of influenza has had promising results in trials.

6 Jan 2008

Watson Pharmaceuticals launches generic Biaxin

Watson Pharmaceuticals, Inc. has announced it has launched Clarithromycin Extended-Release Tablets, USP in the 500 mg strength.

4 Jan 2008

Prescription drug ads on television minimize risk information

Prescription drug ads on television first hit the airwaves just over a decade ago, but a new University of Georgia study finds that most of them still do not present a fair balance of information, especially when it comes to the risk of side effects.

4 Jan 2008

Sanofi Pasteur enters agreement eith Crucell for next-generation biologicals against rabies

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that it has signed an exclusive collaboration and commercialization agreement with Crucell N.V. for Crucell's rabies monoclonal antibodies (MAbs), next-generation rabies biologicals to be used in association with rabies vaccine for post-exposure prophylaxis against this fatal disease.

4 Jan 2008

FDA reviews new data on risks of erythropoiesis-stimulating agents

The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs.

4 Jan 2008

Big pharma spends almost twice as much on marketing drugs than on research and development

The pharmaceutical industry spends almost twice as much on the marketing and promotion of drugs than on research and development, according to a new analysis in this week's PLoS Medicine.

4 Jan 2008

Watson receives FDA approval for generic DuoNeb

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.).

3 Jan 2008

Avoiding overuse, misuse, and underuse of medications

Adverse drug events are more common in older adults because they are prescribed more drugs and are effected differently by these drugs than their younger counterparts.

3 Jan 2008

Barr receives approval for generic KYTRIL tablets

Barr Pharmaceuticals, Inc. has announced that its subsidiary, Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Roche Laboratories Inc.'s KYTRIL (granisetron hydrochloride) Tablets, 1mg (eq to 1 mg base).

3 Jan 2008

AstraZeneca submits sNDAs for SEROQUEL XR for bipolar symptoms

AstraZeneca has announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

3 Jan 2008

Perrigo receives FDA OK for OTC Cetirizine Hydrochloride tablets

Perrigo Company has announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg.

2 Jan 2008

Mylan announces FDA approval for Cetirizine Hydrochloride tablets

Mylan Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.

2 Jan 2008

Ensuring heart safety of non-heart drugs

Current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of drugs developed primarily for non-cardiovascular medical problems, according to a recent presentation made by Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City.

2 Jan 2008