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Medical Marketing and Media - Seniors flunk DTC retention

admin — Fri, 09 Jan 2009 02:16:02 +0000

Nearly 300 men aged 60-75 (statistically the age group most at risk for benign prostatic hyperplasia, or BHP), failed miserably to retain product risk information presented to them once a week for three weeks in DTC ads for Abbott’s Hytrin, according to an FDA-linked, self-funded study published in the current issue of the Drug Information Journal.

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Knight Ridder/Tribune Business News - Abbott to Pay Miami-Based Ivax $45 Million to Settle Suit.

admin — Mon, 05 Jan 2009 01:56:02 +0000

The Miami Herald Knight Ridder/Tribune Business News
Apr. 4–Illinois-based Abbott Laboratories has agreed to pay Miami-based Ivax Corp. as much as $45 million over the next two years to settle a lawsuit stemming from a dispute over a generic drug to treat high blood pressure.
In 1996, Ivax’s Zenith Laboratories subsidiary sued Abbott in U.S. District Court in Newark, N.J., claiming Abbott interfered with Zenith’s ability to win government approval for and sell a generic version of Abbott’s Hytrin.

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Read the rest of this article with a Free Trial at HighBeam Research.

Drug Store News - Warner Chilcott files ANDA for terazosin hydrochloride capsules

admin — Thu, 01 Jan 2009 02:31:02 +0000

Warner Chilcott PLC has filed an abbreviated new drug application with the FDA for an AB rateable form of terazosin hydrochloride capsules, said to be a bioequivalent of Abbott Laboratories’ Hytrin alpha blocker.

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Chain Drug Review - Mylan Approval

admin — Sat, 27 Dec 2008 01:31:03 +0000

PITTSBURGH — Mylan Laboratories Inc. has received approval from the FDA to manufacture and market terazosin hydrochloride capsules, the generic equivalent to Abbott Laboratories’ Hytrin.

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Chain Drug Review - Novartis settles dispute with FTC

admin — Tue, 23 Dec 2008 02:51:02 +0000

Geneva Pharmaceuticals Inc., a unit of Novartis AG, has settled claims by the Federal Trade commission that an agreement it has with Abbott Laboratories over the marketing of a generic drug violated antitrust regulations. The case involves a generic version of Abbott’s Hytrin produced by Geneva.

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Business Wire - Aphios Awarded SBIR Grant From NCCAM, NIH for Standardized & Improved Saw Palmetto Product

admin — Thu, 18 Dec 2008 20:16:03 +0000

Business/Technology Editors & Health/Medical Writers
WOBURN, Mass.–(BW HealthWire)–Oct. 3, 2000
Aphios Corporation has been awarded a SBIR grant from the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH) for developing a standardized and improved Saw Palmetto product.”
Saw Palmetto, derived from the Native American palm tree Serenoa repens, has been clinically proven to be as effective as conventional medications in providing symptomatic relief for benign prostatic hyperplasia (BPH), a non-malignant prostate enlargement that is common in older men. This condition typically causes frequent urination. Products, such as Saw Palmetto, are however being manufactured without any significant regard to the standardization, reproducibility and validity of the manufacturing process, or the content and quality of the active ingredients.

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Aphios Corporation is improving the quality and manufacturing of Saw Palmetto by utilizing its proprietary SuperFluids(TM), supercritical fluids and near-critical fluids w/wo polar cosolvents such as alcohols, technology. These fluids are gases such as carbon dioxide that, when compressed, exhibit enhanced thermodynamic properties that can be “fine-tuned” for rapid and selective extraction of bioactive molecules. SuperFluids(TM) provide the opportunity for more rigorous standardization of nutraceuticals and potential herbal Rx products such as Saw Palmetto and for achieving formulations, which may not be possible with conventional organic phase manufacturing. Such products are also free of toxic organic solvents, environmentally friendly and truly “green.”
In this program, Aphios Corporation is collaborating with Paracelsian, Inc., Ithaca, NY to develop an enhanced and standardized Saw Palmetto product. Paracelsian, Inc., has developed a BioFIT(TM) “functional” quality assurance in vitro biological assays for Saw Palmetto. The BioFIT(TM) system incorporates both human digestive and bioavailability models for defining and validating “structure/function” claims for herbal products.
Currently, there are three drugs approved by the FDA to treat the symptoms of BPH - Proscar(R), Hytrin(R) and Cardura(R), with estimated combined sales of over $1.5 billion. In the U.S., an estimated 30 million men over 50 have enlarged prostates. The incidence of BPH for men in their fifties is 50% and rises to 80% by the age of 80. Conventional drugs for BPH cause diminished libido and sexual dysfunction in some patients and, in certain cases, about 3-4% of patients experiences impotence. Saw Palmetto is a natural alternative to these drugs - it is effective with fewer side effects.
Aphios Corporation (www.aphios.com) is a “green” biopharmaceutical company, which is developing enhanced natural therapeutics for health maintenance and the treatment of human diseases with a focus on CNS, cancer and infectious diseases. Aphios’ principal research and manufacturing facilities are in Massachusetts at 3-E Gill Street, Woburn, MA 01801, USA, tel.: (781) 932-6933, fax: (781) 932-6865, e-mail: aphios@aol.com. For more information, visit our web site at: http://www.aphios.com.
COPYRIGHT 2000 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

Business Wire - Mylan Laboratories Settles United Wisconsin Services Suit; Class Action Lawsuit Accused Drug Manufacturer of Unfair Prices on Lorazepam and Clorazepate

admin — Fri, 12 Dec 2008 00:56:04 +0000

Business Editors
MILWAUKEE–(BUSINESS WIRE)–Feb. 2, 2001
United Wisconsin Services, Inc., a Milwaukee-based health insurer, has entered into a Stipulation of Settlement with Mylan Laboratories, Inc. which, subject to court approval, will settle class action litigation on behalf of health insurers and other third party payers concerning prices paid in 1998 and 1999 for the generic versions of the prescription drugs lorazepam, and clorazepate.

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Pursuant to the agreement, Mylan will pay $25 million and a third party will pay an additional $285,000 to settle all claims of third party payers for payments made on behalf of users of lorazepam and clorazepate in 19 states and the District of Columbia. In a separate class action lawsuit, in which United Wisconsin Services is not a party, Mylan has agreed to pay $10 million to settle third party payer claims in the other 31 states. Mylan has also agreed to settle separate lawsuits brought by the Federal Trade Commission and state attorneys generals.
United Wisconsin Services sued in the United States District Court for the District of Columbia in May 1999, charging Mylan with violating various states’ antitrust and consumer protection laws by conspiring with raw material suppliers to corner the market for the active pharmaceutical ingredients used to make generic lorazepam and generic clorazepate. United Wisconsin charged that this prevented Mylan’s competitors from manufacturing generic lorazepam and generic clorazepate, enabling Mylan to raise prices for these drugs dramatically, at the expense of consumers and third party payers. United Wisconsin Services was later joined in the lawsuit by Blue Cross Blue Shield of Kansas and Carefirst Blue Cross Blue Shield (Washington, D.C.).
United Wisconsin Services is a provider of managed healthcare services and employee benefits products through its subsidiaries, Blue Cross & Blue Shield United of Wisconsin, Inc., Compcare Health Insurance Corporation, Unity Health Plans Insurance Corporations and Valley Health Plan Incorporated. United Wisconsin Services serves markets in Wisconsin and 39 other states and provides managed care benefits to persons in all states.
“We must do what we can to hold down the skyrocketing cost of pharmaceuticals,” said Thomas R. Hefty, chairman, president and CEO of United Wisconsin Services Inc. “When drug companies engage in unfair trade practices, it’s important for us to do something about it.”
United Wisconsin Services has been a leader among managed care companies in using litigation to redress unfair trade practices which increase prescription drug costs to the United States healthcare system. United Wisconsin is currently prosecuting three other class action lawsuits concerning unfair trade practices which increased prices paid by consumers and third party payers for the prescription drugs Cardizem CD (diltiazem hydrochloride), Hytrin (terazosin hydrochloride), and Coumadin (warfarin sodium). United Wisconsin Services is represented in these class action cases by the law firm of Lowey Dannenberg Bemporad & Selinger, P.C., White Plains, New York.
Headquartered in Milwaukee, United Wisconsin Services operates Wisconsin’s largest health maintenance organization system, and it includes CompcareBlue, Unity Health Plans and Valley Health Plan. The company also has substantial specialty insurance products and services operations.
COPYRIGHT 2001 Business Wire
COPYRIGHT 2001 Gale Group

Nutrition Action Healthletter - Palmetto and the Prostate

admin — Sat, 06 Dec 2008 20:06:02 +0000

You find that you no longer can sit through a movie or a long car room. And sometimes when you get there, not much happens.
The problem: a swollen prostate gland, or benign prostatic hypertrophy (BPH). It plagues one out of every two men over the age of 60. If the enlarged gland presses against the urethra, the tube that carries urine from the bladder out of the body, the simple act of urinating can become difficult.
Surgery can open up the flow, but because the prostate is surrounded by nerves, patients run the risk of incontinence or impotence. Prescription drugs provide some relief for some men, but with the risk of diminished sex drive (Proscar) or dizziness (Hytrin). And there’s no good evidence that changing your diet will help.

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But saw palmetto might. Since we last looked at prostate supplements (see “P’ is for Prostate,” June 1996), the evidence for this berry extract has gotten stronger.
Berry Good
Native Americans traditionally used the berries of the saw palmetto plant to treat the symptoms of urinary tract problems. Since 1983, seven good European studies have compared standardized saw palmetto extracts with look-alike (but palmetto-less) placebos in men with urinary problems caused by BPH. About 350 men took the extracts for one to three months.
In five of the seven studies, saw palmetto was better than the placebo in relieving some symptoms. On average, the saw-palmetto-taken felt less urgency to urinate, got up less often at night to go to the bathroom, or had greater urine flow.
In another large study, European researchers gave either saw palmetto or the prescription drug Proscar to more than 1,000 men for six months.(1) Both proved equally effective in relieving–but not eliminating–the symptoms of BPH (though both failed to help about a third of the men). While Proscar was better at increasing the maximum rate of urine flow and shrinking the prostate, the men taking saw palmetto reported fewer problems with sex drive and performance.
Results like these led the United States Pharmacopoeia (USP) to conclude last April that there is “moderate evidence of effectiveness” for saw palmetto in men with BPH. USP is a quasi-governmental agency that sets manufacturing standards for drugs and advises health professionals on their appropriate use.
Saw palmetto appears to be safe, causing no more short-term side effects than a placebo. Still, there are no long-term studies looking at possible side effects in humans. Probably the biggest risk is taking saw palmetto to relieve the discomfort of BPH without first seeing your physician to rule out prostate cancer, which can have the same symptoms.
What to Take?
Which brand is best? The studies showing that saw palmetto can help relieve the symptoms of BPH used:
* extracts of saw palmetto berries, not crushed whole berries,
* a typical 320-mg dose (160 mg taken twice a day),
* extracts containing at least 85 percent fatty acids, which are likely to contain the active ingredients.
Your chances of getting the right amount of the right ingredients are about two out of three, according to a survey by a supplement testing company, consumerlab.com.
“Only 17 of the 27 leading brands of saw palmetto we purchased at the end of 1999 passed our test,” says consumerlab.com president Tod Cooperman.
Six of the 27 didn’t claim to contain 85 percent fatty acids. When the company analyzed the remaining 21 brands, 17 passed.
The company tested only one sample of each brand. But its results are the only ones available. (For a list of brands that passed, see www.consumerlab.com.)
(1) Prostate 29: 231, 1996.
For more information and links to the studies mentioned in this article, see www.cspinet. org/nah/sawpalmetto.html.
COPYRIGHT 2000 Center for Science in the Public Interest
COPYRIGHT 2004 Gale Group

Encyclopedia of Alternative Medicine - Saw palmetto

admin — Sun, 30 Nov 2008 11:26:02 +0000

Description
Saw palmetto is an extract derived from the deep purple berries of the saw palmetto fan palm (Serenoa repens), a plant indigenous to the coastal regions of the southern United States and southern California. There is an estimated one million acres of wild saw palmetto palms in Florida, where the bulk of commercial saw palmetto is grown.
General use
Saw palmetto is used by natural health practitioners to treat a variety of ailments in men and women, such as testicular inflammation, urinary tract inflammation, coughs, and respiratory congestion. It is also used to strengthen the thyroid gland, balance the metabolism, stimulate appetite, and aid digestion. Most of the evidence supporting these uses is anecdotal and has not been proven by controlled clinical trials. However, there is much scientific documentation outlining the effectiveness of the herb in treating irritable bladder and urinary problems in men with benign prostate hyperplasia (BPH), an enlargement of the prostate gland. BPH results in a swelling of the prostate gland that obstructs the urethra. This causes painful urination, reduced urine flow, difficulty starting or stopping the flow, dribbling after urination, and more frequent nighttime urination. Saw palmetto does not reduce prostate enlargement . Instead, it is thought to work in a variety of ways. First, it inhibits the conversion of testosterone into dihydrotestosterone (DHT). BPH is thought to be caused by an increase in testosterone to DHT. Secondly, saw palmetto is believed to interfere with the production of estrogen and progesterone, hormones associated with DHT production.
In addition to causing pain and embarrassment, BPH can lead to serious kidney problems if undiagnosed and left untreated. It is a common problem in men over the age of 40. Estimates are that 50-60% of all men will develop BPH in their lifetimes. The Agency for Health Care Policy and Research estimates there are six million men between the ages of 50-79 who have BPH serious enough to require some type of therapy. Yet only half of them seek treatment from physicians. Health practitioners in both the allopathic and natural medicine communities recommend annual prostate exams for men over the age of 50, and an annual blood test that measures prostate specific antigen, a marker for prostate cancer.
Recently, a number of clinical trials have confirmed the effectiveness of saw palmetto in treating BPH. Many of these trials have shown saw palmetto works better than the most commonly used prescription drug, Proscar. Saw palmetto is effective in nearly 90% of patients after six weeks of use, while Proscar is effective in less than 50% of patients. In addition, Proscar may take up to six months to achieve its full effect. Since Proscar blocks the production of testosterone, it can cause impotence and breast enlargement. Also, saw palmetto is significantly less expensive than Proscar. A one month supply of saw palmetto costs $12-25, while a one month supply of Proscar costs $65-75. Other prescription drugs used to treat BPH are Cardura (doxazosin), Hytrin (terazosin), and Flomax (tamsulosin hydrochloride). Originally prescribed to treat hypertension, Cardura and Hytrin can drop blood pressure, causing lightheadedness and fainting. Presently, saw palmetto is being evaluated by the U.S. Food and Drug Administration (FDA) for treatment of BPH. If approved, it would become the first herbal product to be licensed by the agency as a treatment for a specific condition. Saw palmetto is listed in the Physicians Desk Reference for Herbal Medicine (1998 Edition) as a treatment for prostate complaints and irritable bladder.

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Since the 1960s, extensive clinical studies of saw palmetto have been done in Europe. A review of 24 European trials appeared in the November 1998 issue of the Journal of the American Medical Association. The trials involved nearly 3,000 men, some taking saw palmetto, others taking Proscar, and a third group taking a placebo. The men taking saw palmetto had a 28% improvement in urinary tract symptoms, a 24% improvement in peak urine flow, and 43% improvement in overall urine flow. The results were nearly comparable to the group taking Proscar and superior to the men taking a placebo.
Uses in women
There is very little documentation or scientific research into saw palmetto use in women. However, several studies in the 1990s show that the BPH drug Proscar can be effective in stopping unwanted facial and body hair growth, and in treating thinning hair in women. It works by blocking the action of an enzyme called 5-alpha reductase. Anecdotal reports suggest that saw palmetto may be as effective as Proscar in treating unwanted hair growth and thinning hair, and in preventing some types of acne. It has also been used to treat urinary tract inflammation and help relieve the symptoms of menstruation. There are claims it can be used to enlarge breasts, but these claims have not been scientifically tested.
History
Saw palmetto berries have been used in American folk medicine for several hundred years as an aphrodisiac and for treating prostate problems. Native Americans in the southeast United States have used saw palmetto since the 1700s to treat male urinary problems. In the 1800s, medical botanist John Lloyd noted that animals that ate saw palmetto appeared healthier and fatter than other livestock. Early American settlers noticed the same effects and used the juice from saw palmetto berries to gain weight, to improve general disposition, as a sedative, and to promote reproductive health.
In the United States, the medicinal uses of saw palmetto were first documented in 1879 by Dr. J.B. Read, a physician in Savannah, Georgia, who published a paper on the medicinal benefits of the herb in the April 1879 issue of American Journal of Pharmacy. He found the herb useful in treating a wide range of conditions. “By its peculiar soothing power on the mucous membrane it induces sleep, relieves the most troublesome coughs, promotes expectoration, improves digestion, and increases fat, flesh and strength. Its sedative and diuretic properties are remarkable,” Read wrote. “Considering the great and diversified power of the saw palmetto as a therapeutic agent, it seems strange that it should have so long escaped the notice of the medical profession.”
A pungent tea made from saw palmetto berries was commonly used in the early 1900s to treat prostate enlargement and urinary tract infections. It was also used in men to increase sperm production and sex drive, although these uses are discounted today. One of the first published medical recommendations that saw palmetto was effective in treating prostate problems appeared in the 1926 edition of United States Dispensatory. In the late 1920s, the use of medicinal plants, including saw palmetto, began to decline in the United States, while at the same time, it was on the rise in Europe.

All About the Tadalafil Pills

admin — Sun, 23 Nov 2008 15:51:03 +0000

Tadalafil is used for the treatment of erectile dysfunction (impotence).

How should this medicine be used ?

Take Tadalafil tablets by mouth. Follow the directions on the prescription label. The dose is usually taken 30 minutes to 1 hour before sexual activity. You should not take this dose more than once per day. Swallow the tablets with a drink of water. You may take Tadalafil with or without meals. Do not take double or extra doses. Do not change your dose without talking to your prescriber. Your prescriber may lower or raise your dose, depending on how your body reacts to Tadalafil. If you have kidney or liver problems or are taking certain medications, your prescriber may limit your dose of Tadalafil.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. At this time, this medicine is not for use in children.

What if I miss a dose ?

This does not apply. However, do not take double or extra doses.

What drug(s) may interact with Tadalafil?

Do not take Tadalafil if you are taking the following medications:

alpha blockers, such as alfuzosin (UroXatral), doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin), used to treat high blood pressure or an enlarged prostate. Flomax (tamsulosin) 0.4 mg daily may be taken with Cialis.

nitroglycerin-type drugs for the heart or chest pain such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, even if these are only taken occasionally

Tadalafil may also interact with the following medications:

bosentan

certain antibiotics such as clarithromycin, erythromycin, troleandomycin

certain drugs used for seizures such as carbamazepine, phenytoin, and phenobarbital

cimetidine

cisapride

diltiazem

grapefruit juice

medicines for fungal infections (fluconazole, itraconazole, ketoconazole, voriconazole)

mibefradil

nicardipine

certain medicines for the treatment of HIV infection or AIDS

quinidine

rifabutin, rifampin or rifapentine

some drugs for treating depression, anxiety or other mood problems (examples: fluoxetine, fluvoxamine, nefazodone)

verapamil

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from receiving Tadalafil ?

Side effects that you should report to your prescriber or health care professional as soon as possible:

changes in vision

chest pain or palpitations

difficulty breathing, shortness of breath

dizziness

eyelid swelling

prolonged erection (lasting longer than 4 hours)

skin rash, itching

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

back pain

flushing

headache

indigestion

muscle aches

stuffy or runny nose

What should I watch for while taking Tadalafil ?

Contact your physician immediately if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated immediately to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after Cialis use, you should refrain from further activity and should discuss the episode with your prescriber or health care professional as soon as possible.

Do not drink alcohol to excess (examples, 5 glasses of wine or 5 shots of whiskey) when taking Cialis. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate or lowering your blood pressure.

If you notice any changes in your vision while taking this drug, notify your prescriber or health care professional as soon as possible.

Do not change the dose of your medication. Please call your prescriber or health care professional to determine if your dose needs to be reevaluated.

Using Cialis does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

Where can I keep my medicine ?

Keep out of reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

If you want to purchase Cialis then do it with us.With our help buying drugs online is safe and secure.