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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

Wyeth wins HRT trial

Wyeth has announced that the jury in the case of Merle and Steven Simon v. Wyeth, in the Philadelphia Court of Common Pleas, found in favor of Wyeth.

16 May 2007

Lupin Pharmaceuticals receives FDA approval for Simvastatin tablets

Lupin Pharmaceuticals, Inc. has announced that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg.

16 May 2007

FDA approves Evicel Fibrin surgical sealant

The U.S. Food and Drug Administration (FDA) has approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from small blood vessels during surgical procedures.

16 May 2007

FDA approves Dey, L.P.'s NDA for chronic obstructive pulmonary disease inhalation solution

Dey, L.P. has announced that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD).

15 May 2007

New blood pressure drug derived from sea creature promises to save millions of lives

Scientists in Britain say they have developed a new vaccine for people suffering from hypertension; they say the vaccine will control blood pressure and has the potential to save millions of lives.

15 May 2007

FluMist gets FDA green light

The Food and Drug Administration (FDA) in the United States says FluMist, an influenza vaccine made by MedImmune appears to be safe for young children even though the influenza vaccine is still under review.

15 May 2007

Patch to treat Parkinson's gets FDA green light

The Food and Drug Administration (FDA) in the United States has given it's approval for the first patch for Parkinson's disease.

14 May 2007

FDA Panel warns anemia drug dangerous for cancer patients

A panel of experts advising the Food and Drug Administration (FDA) in the United States has warned that the popular anemia drug erythropoietin may not be as safe as first thought.

14 May 2007

FDA announces results of investigation into illegal promotion of OxyContin

The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) has announced that The Purdue Frederick Company, Inc. has agreed to pay more than $700 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.

11 May 2007

FDA issues consumer warning for "True Man" or "Energy Max" products

The Food and Drug Administration (FDA) is advising consumers not to purchase or use "True Man" or "Energy Max" products promoted and sold as dietary supplements throughout the United States.

11 May 2007

Low frequency of resistance to Tamiflu confirmed

New data published by the World Health Organisation (WHO) has confirmed a low frequency of resistance to Tamiflu (oseltamivir) over 3 influenza seasons (2003:2006).

10 May 2007