November 2006 Archives

November 29, 2006 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise that use of central nervous system stimulants may increase the risk for cardiovascular events and exacerbate psychotic symptoms in certain patients and that chronic use may cause temporary suppression of growth rate in children. Also, interferon-alfa-2a [recombinant] subcutaneous injection may be linked to potential risks for severe infection and pancreatitis.

CNS Drugs May Potentiate Risk for Sudden Death

The FDA approved safety labeling revisions in August for dexmethylphenidate HCl tablets and extended-release capsules (Focalin and Focalin XR, made by Novartis Pharmaceuticals Corp), methylphenidate HCl extended-release capsules (Metadate CD, made by UCB Pharma, Inc), methylphenidate chewable tablets/oral solution (Methylin, made by Mallinckrodt), and methylphenidate tablets, sustained-release tablets, and extended-release capsules (Ritalin, Ritalin SR, and Ritalin LA, made by Novartis Pharmaceuticals Corp).

CHICAGO (Reuters) - Private insurers in the Medicare insurance program were paid 12.4 percent more by the government than the health care provided would have cost under traditional Medicare, a report released on Thursday said.

Payments to private insurers were $922 more per enrollee in 2005 than they would have been to the government-run program, the report by the nonprofit research group the Commonwealth Fund said.

Private managed-care companies have taken a bigger role in Medicare, the health insurance program for 43 million elderly, after recent changes pushed by President George W. Bush and the Republican-led U.S. Congress.

BOSTON (Reuters) - Scientists assigned to monitor the ethics of medical studies often help decide whether to approve research even when they have financial ties to the company sponsoring the work, a study shows.

Almost one-third of those polled said they "sometimes" or "always" voted on research projects where they had a relationship with the sponsor or the experiment was sponsored by a company competing with one they were financially linked with.

Under federal regulations, researchers who review medical experiments are supposed to avoid conflicts of interest so that patients who volunteer in studies are not subject to reckless research in which scientists might make a profit.

Thirty years ago in America the consensus was a 35-year-old person was middle-aged. Thirty years later that same person can still claim to be middle-aged, according to a new survey released on Monday.

Global research group AC Nielsen surveyed people in 42 countries and found 60 percent of Americans, the world's biggest consumers of cosmetic surgery and anti-aging skincare, believe their sixties are the new middle age.

Cosmetic surgery is altering not just how people look but how they feel by changing perceptions of middle age.

HealthDay News -- A group representing America's obstetricians is recommending that women avoid the antidepressant Paxil if they are pregnant or planning on becoming pregnant, due to a potential heightened risk for birth defects.

The American College of Obstetricians and Gynecologists (ACOG) also cautioned that treatment with other antidepressants should be considered on a case-by-case basis.

ACOG's Committee on Obstetric Practice "recommends that treatment with all SSRIs [selective serotonin reuptake inhibitors] or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine [Paxil] use among pregnant women or women planning to become pregnant be avoided, if possible," read the statement, which is in the December issue of Obstetrics & Gynecology.

SAN FRANCISCO (MarketWatch) -- Dynavax Technologies Corp. shares soared as much as 44% Wednesday to reach their highest level ever after the company said its experimental hepatitis B vaccine protected all of the patients it tested in a late-stage clinical trial.

Shares of the Berkeley, Calif.-based drugmaker (DVAX) were changing hands for $9.96 in afternoon trading, up $2.56 and off an earlier high of $10.66.

Dynavax said that after three doses, its Heplisav vaccine protected 100% of a "difficult-to-immunize" population of adults aged 40 to 70 years compared with GlaxoSmithKline PLC's (GSK) Engerix-B vaccine, which was found to protect 73.1% of such people. In those ranging from 56 to 70 years of age, Heplisav's rate of protection was similarily 100% vs. a 56.1% rate for Engerix-B.

HealthDay News -- Aspirin is often recommended by cardiologists for its blood-thinning properties, but the medication can lead to complications, including stomach problems.

The Cleveland Clinic says you should always check with your doctor before starting a daily aspirin regimen.

In general, the clinic says, people at risk for the following conditions may benefit from aspirin therapy:

• Heart attack
• Blood clots or stroke caused by blood clots
• Unstable angina
• Transient ischemic attacks (TIAs) or "mini-strokes

source - Healthday

(Houston Chronicle (KRT) Via Thomson Dialog NewsEdge) Nov. 28--In September 2004, when pharmaceutical giant Merck withdrew its best-selling painkiller Vioxx amid concern over potentially fatal side effects, many of the nation's plaintiff lawyers were wide-eyed with anticipation.

Ominous headlines had circulated for years, prompted by studies that indicated Vioxx increased the risk of a heart attack or stroke. Merck's decision to withdraw the drug from the market, despite annual sales of $2.5 billion, was an invitation for lawsuits.

A trickle grew into a steady stream and eventually a torrent of litigation. The plaintiffs' prospects looked good, especially after the New England Journal of Medicine published an editorial accusing Merck of concealing heart attacks suffered by individuals who were part of a Vioxx study reported in the prestigious magazine in 2000.

Pfizer Inc. may fall short in convincing federal regulators that its painkiller Celebrex should receive expanded approval to treat children with a devastating form of arthritis, according to documents released Tuesday.

Pfizer wants Food and Drug Administration approval to sell Celebrex as a treatment for juvenile rheumatoid arthritis, or JRA, which affects as many as 60,000 U.S. children. The disease causes painful joint swelling and can affect growth and development.

However, an FDA review of the New York company's application questions whether the drug works for the pediatric disease. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998.

NEW YORK (CNNMoney.com) -- Pfizer said it would cut its U.S. sales force by 20 percent as part of an ongoing effort to reduce costs.

Pfizer (up $0.08 to $27.05, Charts), the world's biggest drug company, announced the impending job cuts in the form of a press release but did not say when the reductions would take place.

The job cuts, which will affect some 2,200 workers, are coming from all levels of Pfizer's sales organization - from senior management to field representatives, Pfizer spokesman Paul Fitzhenry told Reuters.

With flu-shot season in full swing and widespread anticipation of the HPV vaccine to prevent cervical cancer, a new University of Rochester study suggests that using common painkillers around the time of vaccination might not be a good idea.

Researchers showed that certain nonsteroidal anti-inflammatory drugs (NSAIDs), also known as cyclooxygenase inhibitors, react with the immune system in such a way that might reduce the effectiveness of vaccines.

The research has widespread implications: study authors report that an estimated 50 to 70 percent of Americans use NSAIDs for relief from pain and inflammation, even though NSAIDs blunt the body's natural response to infection and may prolong it.

VANCOUVER, BRITISH COLUMBIA--(CCNMatthews - Nov. 28, 2006) - A major national research project, co-led by Drs. Bruce Carleton and Michael Hayden, to improve drug safety for children, today received a major contribution of $500,000 from Pfizer Canada Inc. The project, named Genotype-Specific Approaches to Therapy in Childhood (GATC), receives major funding from a Genome Canada/Genome BC-sponsored research program and is led from two research centres within the Child & Family Research Institute (CFRI) at BC Children's Hospital.

A failure of modern medicine is the debilitating and lethal consequences of adverse drug reactions (ADRs) which rank as one of the leading causes of death and illness in North America. Children are at a greater risk for severe ADRs, yet there remains a lack of understanding of their causes due in part to an inability to conduct pediatric patient studies of similar rigour and scope as in adult populations. The goal of GATC is to promote the health and well-being of Canadian children and of the global pediatric community by developing cost-effective interventions to reduce life-long disabilities and deaths caused by severe ADRs. The project will identify pediatric patients experiencing ADRs, collect DNA samples, apply genomics-based technologies to identify ADR-associated genetic markers and help predict and prevent drug toxicity.

SAN FRANCISCO (Reuters) - With California facing a $5.5-billion budget gap, Gov. Arnold Schwarzenegger may have to pare his goal of providing health-care coverage to the nearly 7 million uninsured in the state, analysts said on Monday.

The Republican governor crushed his Democratic challenger in an easy re-election victory this month, and aims to use the political momentum to push a plan that on its face should excite California's Democrat-led legislature.

But observers of the state's political scene wonder where money for the plan, which aides are writing, would come from.

"The math doesn't add up," said Larry Gerston, a political scientist at San Jose State University. "I don't understand the means at the moment."

BEIJING (Reuters) - China, responding to complaints from the public, has banned advertisements for medical treatments and procedures in a bid to halt bogus claims of wonder drugs and clean up an unregulated health industry.

The ban would cover advertising on television, radio and in newspapers and take effect on Jan 1, the Beijing News said on Tuesday.

It would ban guarantees of effectiveness, and the "use of sufferers" and medical personnel to promote treatments and procedures.

The successful synthesis of an antibiotic in a non-native host has provided a team of researchers at the University of Illinois at Urbana-Champaign with the potential for developing new treatments for bacterial infections.

The rapid rise of antibiotic resistance poses a serious threat to human health, and demands new treatments effective against resistant pathogens. Fosfomycin is a natural antibiotic approved by the Food and Drug Administration for the treatment of various bacterial infections, and has proven effective for the treatment of infections that have become resistant to the antibiotics penicillin and vancomycin.

Fosfomycin is a member of a class of compounds called phosphonic acids because they contain a carbon-phosphorous bond. Fosfomycin functions by inactivating an essential enzyme involved in the formation of the bacterial cell wall.

Bayer AG, Germany's largest drugmaker, said third-quarter profit fell less than analysts estimated and raised the earnings forecast for its pharmaceuticals unit after the 17 billion-euro ($22.3 billion) purchase of Schering AG.

Net income fell 35 percent to 320 million euros, or 42 cents a share, from 493 million euros, or 68 cents, a year earlier, Leverkusen-based Bayer said today. That exceeded the 195 million euro median estimate of nine analysts surveyed by Bloomberg. Sales rose 26 percent to 7.78 billion euros.

Schering's Betaferon multiple sclerosis treatment and Yasmin birth-control pills led the drug unit's gain. Bayer expanded the drug division as governments and health insurers around the world cut health-care spending by trimming prices and using generic medicines. Bayer will close sites in the U.S. in a plan to slash expenses by 700 million euros a year to counter higher raw material costs and the crop-science unit's falling profit.

Nov 27 (Reuters) - Cytokinetics Inc. (CYTK.O: Quote, Profile, Research) said it will be responsible for the costs and activities of further development of two cancer drug candidates following an amendment of a collaboration agreement with GlaxoSmithKline plc (GSK.N: Quote, Profile, Research).

The company also lowered its 2006 revenue outlook to $3 million to $4 million, with research and development expense of $52 million to $56 million. Analysts on average were expecting the company to report revenue of $3.8 million, according to Reuters Estimates. (Reporting by Hari Kumar in Bangalore)

© Reuters 2006.

People starting treatment with methadone have died and suffered life-threatening side effects, health officials said Monday in warning of the dangers of overdosing on the painkiller.

Overdoses of the increasingly popular narcotic can cause slow or shallow breathing and dangerous changes in heart beat that patients might not feel, the Food and Drug Administration said.

Those side effects, including reports of deaths, have been seen in patients starting methadone treatment for severe pain or who switched to the drug after using other strong narcotic pain relievers, the FDA said in a public health advisory.

The FDA warned that methadone only provides pain relief for four to eight hours, but can linger in the body for eight to 59 hours. That can lead patients to take more of the drug before it has been eliminated by the body, causing the drug to build up in the body to toxic levels, the FDA said.

BALTIMORE, Md. - Alba Therapeutics Corporation announced today that it secured a $10 million venture debt commitment from a syndicate consisting of Atel Ventures, Inc., Oxford Finance Corporation and SVB Silicon Valley Bank. This additional source of capital will enable the company to accelerate the clinical development of AT-1001 in celiac disease and other autoimmune indications during 2007.

AT-1001 is an orally administered zonulin receptor antagonist that is currently under investigation in a multicenter, double blind, placebo controlled Phase II dose ranging study to evaluate the safety, tolerability and efficacy of AT-1001 in 79 CD subjects during gluten challenge.

"The promising clinical and preclinical data generated with AT-1001 in celiac disease and other autoimmune conditions warranted that we access this capital in order to expedite activities supporting clinical trials," said Blake Paterson, M.D., Chief Executive Officer of Alba. "We now have the ability to fast track the AT-1001 program to address the enormous unmet needs of celiac patients and others suffering from autoimmune diseases."

Canadian biotech drug maker AEterna Zentaris Inc. said Monday that women enrolled in an early stage clinical trial were able to tolerate its experimental cancer treatment.

In the study, 17 women with gynecological and breast cancers were given increasing doses of AN-152, and tolerated the maximum dose of the treatment well, according to the company.

AEterna Zentaris also said that results hinted at effectiveness of the treatment.

MARYSVILLE, Pa. (AP) — Sierra Lewis was having trouble with her schoolwork. She just couldn't concentrate.

"She's been having problems with staying focused," said her mom, Nancy Lewis of Marysville.

The school, Bible Baptist in Shiremanstown, didn't seem like an issue. It doesn't have a disruptive atmosphere.

So it came back to the 12-year-old and what is often described as Attention-Deficit Hyperactivity Disorder — a persistent pattern of abnormally high levels of activity, impulsiveness or inattention. The answer is usually Ritalin.

WASHINGTON -- Despite Celebrex's well-documented link to higher heart risks, Pfizer Inc. wants permission to sell its painkiller to treat children as young as 2 who have arthritis.

Even as critics call for the drug to be removed from the market, Food and Drug Administration advisers will meet Wednesday to consider the company's request to expand Celebrex use.

Celebrex was the first of a class of new-style painkillers, called cox-2 inhibitors , approved in December 1998, and it is the last one to remain on the market. The drugs were designed to relieve pain without causing the stomach distress associated with other treatments, but they have been plagued by safety concerns. Merck & Co. pulled Vioxx from the market in 2004 after its studies showed the painkiller doubled the risk of heart attacks and strokes. Merck now faces more than 20,000 Vioxx lawsuits. Pfizer, under pressure from the FDA, last year halted sales of another cox-2 inhibitor, Bextra , because of heart risks and potentially fatal skin reactions.

A study into the relationship between an organisation's understanding and use of corporate social responsibility (CSR) and its health and safety practices has revealed problems within the small- and medium-sized (SME) business sector.

A report by Dr Stavroula Leka and Johanna Churchill from the Institute of Work, Health and Organisations at The University of Nottingham claims there is a lack of knowledge in the areas of both CSR and occupational health and that leadership can be a considerable barrier to the prevention of health and safety problems.

The quality of cardiac care for Medicaid patients lags behind the care given to those with HMOs and private insurance according to a new study. The study by Dr. James Calvin, lead study author and director of cardiology at Rush University Medical Center, found Medicaid patients were less likely to receive short term medications and to undergo invasive cardiac procedures. They also had higher in-hospital mortality rates and were less likely to receive recommended discharge care. Differences were fewer and smaller for Medicare patients.

The study is published in the November 21st issue of the Annals of Internal Medicine. In addition to Rush, study participants included Duke University Medical Center, New York University School of Medicine, Northwestern University School of Medicine, University of Cincinnati College of Medicine, and the University of North Carolina at Chapel Hill.

Health Canada is warning Canadian women that use of a birth control patch may increase their risk of developing blood clots in the legs and lungs.

The department, along with drug maker Janssen-Ortho Inc., issued the statement based on research that showed a U.S. formulation of the company's patch contraceptive may be associated with a higher risk of blood clots than oral birth control pills.

"We're taking the precaution of giving people an additional heads up that there's a risk of blood clots with the product," said Health Canada spokesperson Alastair Sinclair.

A CHINESE man has been jailed for eight years for making 60 tonnes of fake sex pills, state media reported today as China cracks down on pirates who copy nearly every type of product.

Xi Yongli and his accomplices sold 21.8 million yuan ($3.6 million) worth of America Number One, Male Exclusive, Great Big Brother – the popular Chinese name for Viagra – and other pills and ingredients promising men vibrant sexual lives, a court in central China's Anhui province found, Xinhua news agency said today.

Xi and his gang received sentences spanning from a little over a year to eight years for making and selling medicine without a licence, selling counterfeits, and illegally processing Sildenafil Citrate – the key ingredient in Viagra, Pfizer Inc's top selling male potency pill.

Isotretinoin is a very effective treatment for severe acne, a condition which can be physically, emotionally, and socially disabling. But the drug can also cause severe birth defects if it is taken by pregnant women. What is the best way to prevent pregnant women from taking the drug, and to prevent women taking it from getting pregnant?

A debate article in PLoS Medicine considers the pros and cons of a new Internet-based system, called iPLEDGE (http://www.ipledgeprogram.com/), which tries to tries to ensure that the drug is dispensed only when there is documentary proof that the patient is not pregnant and is using two forms of birth control.

source - Pharma Lexicon 

The New York Times on Tuesday examined the political debates in Australia over the legalization earlier this year of the medical abortion drug mifepristone and whether to pass legislation that would legalize some forms of cloning of human embryos for therapeutic purposes.

According to the Times, Australians often are divided on so-called "values" issues, but political debates on such issues "do not degenerate into personal attacks" as they sometimes do in the U.S. In addition, political candidates in Australia are "not concerned with playing to religious groups," and the political climate has led to Australian politicians having "candid debates on very emotional subjects," the Times reports.

The Australian Parliament in 2002 banned all types of cloning but called for a review of the ban after three years, and in 2005 a government-appointed committee recommended that therapeutic cloning be legalized.

LONDON - Can taking folic acid supplements reduce the risk of heart disease and stroke? British researchers believe it can.

After analysing evidence from earlier studies, a team of scientists in Britain said on Friday there is enough research that shows folic acid lowers levels of the amino acid homocysteine and reduces the odds of cardiovacular disease.

"The evidence is very persuasive that lowering homocysteine with folic acid will lower your risk of heart attack and stroke by about 10-20 percent," David Wald, of the Wolfson Institute for Preventive Medicine, Barts and the London, Queen Mary School of Medicine and Dentistry in London, said in an interview.

A paper appearing this week in the Public Library of Science journal PLoS Clinical Trials presents findings from a large National Institutes of Health sponsored trial regarding the cardiovascular and cerebrovascular safety of two non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen. The trial was initially conducted to test whether these drugs might prevent or delay the onset of Alzheimer's disease.

The paper describes the occurrence of adverse cardiovascular events, particularly heart attacks and strokes, in some 2500 elderly people who took celecoxib, naproxen, or placebo for up to 3.5 years while participating in the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT). The cardiovascular risk of NSAIDs is currently a controversial and hotly debated topic. One such drug, the selective COX-2 inhibitor rofecoxib (Vioxx) has been withdrawn from the market due to concerns about its cardiovascular safety. There is also debate over the safety of other selective COX-2 inhibitors, including celecoxib. Not much data from randomized trials exists on the long-term safety of non-selective, or "traditional", NSAIDs, such as naproxen.

The US Food and Drug Administration (FDA) and the pharmaceutical industry are in strong negotiations to decide how much drug companies will pay the agency to review new drugs from the end of next year, when the current law expires.

Last week, the FDA's deputy commissioner Scott Gottlieb said that pharma companies should contribute additional funds so the agency can study the drugs' safety once they reach the market.

The US drug industry is now negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the regulator – the outcome could change radically the landscape for pharma companies.

Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market.

by Dennis T. Mangano, Ph.D., M.D.

I was troubled by the recent, near-unanimous decision of the Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee publicly advocating the safety of aprotinin¹ — despite considerable evidence to the contrary,^2,3,4 including our recent study² and the FDA's own initial 1993 warning regarding "kidney toxicity."⁵ We learned after the Advisory Committee's meeting of newly disclosed records of 67,000 patients, yielding data that were consistent with our warnings (renal failure, stroke, and heart failure)² and that were inconsistent with the positions of the committee and Bayer.^1,6

In defending the committee's decision, Dr. Hiatt makes allegations in this issue of the Journal regarding our "transparency" (FDA access to our data).⁷ In fact, there is no question that our independent, nonprofit research groups (the Ischemia Research and Education Foundation [IREF] and the Multicenter Study of Perioperative Ischemia [McSPI] reseasrch group) made every effort to have the FDA review in detail all of the source and derivative data from our study² and all associated documentation and operating procedures.

Covance has invested in mass spectrometer technology that it hopes will give it the edge over other contract research organisations (CROs) in the safety testing of new drug candidates.

The company said it was the first CRO to acquire the technology, which “is fast becoming a new standard for qualitative mass spectrometry that enables faster, more sensitive and more reliable detection and identification of compounds in complex mixtures than existing hybrid time-of-flight systems.”

The Thermo LTQ OrbitrapT is said to produce accurate mass data on drugs and metabolites in almost half the time of other mass spectrometers as well as facilitating metabolism evaluation of a drug candidate at a much earlier stage of the development process.

Impax Laboratories Inc. said Wednesday the U.S. Court of Appeals for the Federal Circuit remanded a patent issue back to the lower court, vacating its ruling that was in favor of Sanofi Aventis LLC.

Hayward-based Impax (OTCBB: IPXL) said the patent relates to the use of riluzole in treating amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

In December, U.S. District Court for the District of Delaware granted a preliminary injunction motion brought by Bridgewater, N.J.-based Aventis, which delayed the entry of Impax's generic version into the market.

NEW YORK (AFP) - A US federal judge refused to allow a class-action lawsuit to proceed against Merck for health problems linked to its Vioxx pain medication, in a major victory for the pharmaceutical giant.

Judge Eldon Fallon, asked by an interstate judicial panel to consider how to handle the thousands of lawsuits filed over Vioxx, said the cases did not meet the criteria for a national class action suit, where one court would hear the case for all plaintiffs.

"While the majority of plaintiffs in this case allegedly suffered either a heart attack or stroke as a result of ingesting Vioxx, the extent of each plaintiffs subsequent injuries varies widely," he said in a 25-page decision.

Biotech drug developer Introgen Therapeutics Inc. on Tuesday said the European Patent Office issued a patent covering the company's platform for killing cancer cells.

The patent, which is one of a family of patents issued to University of Texas and licensed to Introgen exclusively, covers one or more of 40 tumor suppressor genes for inducing programmed cell death in cancer cells.

The company seeks to use synthetic nanoparticles to deliver the genes to cancer cells, and shows promise in treating lung cancers that have spread.

Introgen shares rose a penny to $4.74 in afternoon trading on the Nasdaq.

source - BusinessWeek 

With time -- and medical help -- slipped disc pain gets better. But disc surgery is faster and works better for bad pain, a large U.S. study finds.

The study shows that patients with a "slipped" or "ruptured" disc -- what doctors call a herniated disc --won't get worse or become paralyzed if they don't have surgery. Instead, they can expect to get better over time.

But when patients don't want to wait, surgery can mean a quick end to excruciating pain, says study researcher William A. Abdu, MD, medical director of the spine center at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H.

PDL BioPharma, the Fremont, Calif.- based biopharmaceutical company, said that Swiss Roche will discontinue its agreement with PDL to jointly develop and commercialize daclizumab for organ transplant patients on longer-term maintenance therapy.

The co-development agreement between PDL and Roche will formally terminate in May 2007.

Roche made this decision subsequent to a periodic internal review of its development programs.

China Biopharmaceuticals Holdings, Inc., a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, today announced the completion of all required clinical trials for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever. The trials were conducted in six hospitals throughout China. The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) for manufacturing and marketing approval. The Company anticipates an approval response from the SFDA in the second half of 2007.

Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and the reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria. In China, 30% of the population has suffered from an allergy at least once. The $1.5 billion allergy drug market in China continues to grow at a rate of 15% per year.

LONDON (Reuters) - AstraZeneca Plc said on Wednesday it expected 2006 earnings per share to be at the lower end of its $3.85 to $3.95 forecast range following the launch of a copycat version of its heart drug Toprol XL on Tuesday.

The Anglo-Swedish drugmaker also said it had signed an agreement for Par Pharmaceuticals to distribute an authorised generic version of Toprol XL in the United States.

This follows the launch of an unauthorised copycat formulation by Novartis AG's Sandoz on Tuesday.

(c) Reuters 2006