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FDA approves Torisel (temsirolimus) for advanced kidney cancer

The U.S. Food and Drug Administration (FDA) hasapproved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma.

1 Jun 2007

Mylan receives FDA approval for Azithromycin tablets

Mylan Laboratories Inc. ( NYSE:MYL ) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Azithromycin Tablets, 250 mg and 500 mg.

1 Jun 2007

Pharmacists play critical role in reducing medication discrepancies

Involving pharmacists in obtaining and assessing a patient's medication history before elective surgery can significantly reduce medication discrepancies upon hospital admission.

30 May 2007

Office of Fair Trading's value-based pricing scheme is well-founded, but could increase overall NHS drug spend

A report by the Office of Fair Trading has recommended that pricing of drugs is based not on how much the drug costs to develop, but on the benefit that the drug can bring.

30 May 2007

Natalizumab returns to market

Just months after receiving FDA approval, natalizumab, a medication for the treatment of multiple sclerosis (MS) and other inflammatory disorders, was voluntarily withdrawn by its manufacturers after three patients developed a brain infection known as Progressive Multifocal Leukoencephalopathy (PML).

28 May 2007

More considered approach to the safety of rosiglitazone needed

A calmer and more considered approach to the safety of rosiglitazone (Avandia) - the GlaxoSmithKline treatment for type 2 diabetes - is needed to avoid unnecessary panic among patients, says an Editorial published online and in an upcoming edition of The Lancet.

28 May 2007

FDA completes review of FluMist

MedImmune, Inc. has announced that the U.S. Food and Drug Administration (FDA) has stated the agency has completed its review of all submissions made related to the supplemental biologics license application (sBLA) to extend the age indication of FluMist (Influenza Virus Vaccine Live, Intranasal).

28 May 2007

FDA takes action against unapproved prescription versions of Mucinex

Adams Respiratory Therapeutics, Inc. reports that the Food and Drug Administration (FDA) has announced that companies must stop manufacturing and distributing unapproved timed-release dosage forms containing guaifenesin.

28 May 2007

FDA approves treatment for bacterial vaginosis

Mission Pharmacal has announced that the U.S. Food and Drug Administration (FDA) approved Tindamax (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the United States.

28 May 2007

Contact lens solution found to cause serious infection

The Food and Drug Administration (FDA) in the United States has issued a warning to health care professionals and consumers regarding a certain contact lens solution.

27 May 2007

Guidelines on skin reactions to Epidermal Growth Factor Receptor Inhibitors (EGFRIs)

Skin reactions to a powerful new class of anti-cancer drugs are frequent, but manageable through a simple and rational treatment approach , usually without the need to reduce the dose or interrupt treatment with potentially life-prolonging chemotherapy, according to an article in the May issue of "The Oncologist."

24 May 2007

Lupin receives FDA approval for Ziprasidone Hydrochloride capsules

Lupin Pharmaceuticals has announced that on May 16, 2007 it received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Ziprasidone Hydrochloride Capsules 20mg, 40mg, 60mg and 80mg.

24 May 2007

FDA approves VELCADE plus DOXIL combination for multiple myeloma

Ortho Biotech Products has announced the U.S. Food and Drug Administration (FDA) has approved the use of DOXIL (doxorubicin HCl liposome injection) in combination with VELCADE (bortezomib) for Injection to treat patients with multiple myeloma who have not previously received VELCADE and have received at least one prior therapy.

23 May 2007

Weill Cornell Medical College students help change global health policy

In a move to improve global public health, Weill Cornell Medical College students have helped place a lifesaving heart disease drug onto the World Health Organization's (WHO) list of essential medicines.

22 May 2007

GSK strongly disagrees with conclusions reached in NEJM article on Avandia

GlaxoSmithKline has issued the following response to an article in the New England Journal of Medicine (NEJM) on Avandia (rosiglitazone maleate), a widely used and highly effective treatment for type 2 diabetes.

22 May 2007

Blood-thinning drugs need closer monitoring

Natalie Oake and colleagues report on a meta-analysis of studies that recorded hemorrhages and thromboembolic (blood clot) events in patients taking blood-thinners.

22 May 2007

FDA in trouble over widely used diabetic drug Avandia

A diabetes pill which has been widely used since 1999 is now suspected of increasing the risk of heart attacks for those taking it.

22 May 2007

When is an herbal tea a safe and effective sleep aid?

When is an herbal tea a safe and effective sleep aid, and when is that same tea a risky pharmaceutical choice?

18 May 2007

Ranbaxy receives tentative FDA approval for Fexofenadine hydrochloride tablets

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has announced that RLL has received tentative approval from the U.S. Food and Drug Administration to manufacture and market the antihistamine Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg, and 180 mg.

18 May 2007

FDA committee votes in favor of Acambis' smallpox vaccine

Acambis plc announced that the Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration (FDA) voted unanimously that Acambis' smallpox vaccine, ACAM2000, is both safe and efficacious.

18 May 2007