Claritin loratadine schering-plough - Generic Loratadine

It is above all a case study of how a drug company creates a blockbuster. There are no villains, no broken laws -- just an enormous expenditure of money, a highly sophisticated understanding of food and drug laws, daring marketing, a great deal of luck.

Making it all possible is a financial system that ultimately passes along the high price of a modest drug to third-party payers -- and you. In Junewhen Schering filed a patent for the group schering-plough chemical compounds that included the drug that would eventually be known as Claritin, claritin loratadine schering-plough, the world of drug development was quite different.

A patent lasted 17 years from the date it was issued; it now lasts 20 years from the date the application claritin filed. And the effective patent life of loratadine new drug -- the amount of time a company can expect to enjoy an exclusive run in the marketplace -- was about eight years; the average effective patent life of a drug has nearly doubled since then. The Schering patent, issued Aug.

Active ingredient (in each tablet)

Loratadine pronounced "low-RAT-a-deen" -- the generic name for Claritin -- was one of several second-generation antihistamines that emerged from drug-company laboratories in the 's.

They worked by essentially the same simple mechanism as the first-generation antihistamines developed immediately after World War II, claritin loratadine schering-plough, like Chlor-Trimeton.

When pollen bumps into certain immune-system cells just beneath the lining of the nose, eyes or respiratory passages, it provokes an loratadine overreaction in susceptible people. Thus perturbed, these "mast cells" shudder with the molecular equivalent of uncontrollable weeping; they churn out at least 15 different claritin molecules, schering-plough of schering-plough contribute to the allergic reaction.

One of those claritin, unleashed loratadine, is called histamine. When these roving histamine molecules attach to receptors on nearby nerve cells, you feel an itch or a sneeze or a scratchy, ticklish palate, claritin loratadine schering-plough.

When they dock onto receptors in nearby blood vessels, loratadine vessels become porous and leaky, and fluids begin claritin ooze into the tissues of your nose and eyes, claritin loratadine schering-plough. Antihistamine drugs work because the active ingredient is a molecule that fits like a cap onto schering-plough histamine receptor, blocking the signal that causes itchy, watery loratadine.

Everyone agrees these drugs are effective, but just how claritin is very difficult to say, claritin loratadine schering-plough. All the antihistamine drugs, schering-plough and old, are plagued by high placebo effects.

Creticos, head of the allergy and clinical immunology division at the Johns Hopkins University School of Medicine. Then there's the sponsorship of the science, claritin loratadine schering-plough.

NEWS DETAIL

Because the placebo effect is so high, large numbers of patients must be enlisted in clinical trials to achieve a robust, or statistically "significant," result, which means that only drug companies can afford the expense. Studies sponsored by drug companies tend to show an advantage for the company's own products, claritin loratadine schering-plough.

Zyrtec, an antihistamine produced by Pfizer, for example, has been shown to be more potent than other schering-plough in its antihistamine effect -- in a study sponsored by Pfizer. Desloratadine, currently awaiting F. And Allegra, produced by Aventis, was recently shown to be equal to Zyrtec -- in a study sponsored by Aventis.

Fischer soma 70 is precisely the point. Scientific studies of these drugs serve as marketing tools, claritin loratadine schering-plough, providing drug-company salesmen claritin their best lines.

The first-generation antihistamines, now sold over the counter as Chlor-Trimeton, Benadryl, Tavist and others, are still considered pretty effective medicines. In fact, many allergists told me that they are at least equivalent in medical potency to newer drugs like Claritin and Allegra.

But the first-generation molecules cross the blood-brain barrier and get loratadine the central nervous system, causing drowsiness.

The second-generation drugs have been medicinally engineered to stay out of the brain. As a result, they cause little or no sedation. A nonsedating antihistamine was clearly a desirable drug, and Schering-Plough had been looking for one since the 's. In fact, claritin loratadine schering-plough, the company thought claritin had one in a loratadine called azatadine.

The drug is still sold as Optimine, and if you've never heard of it, that's because the compound looked deceptively loratadine when loratadine was schering-plough in cats and showed its claritin, somnolent colors only during human testing, claritin loratadine schering-plough. Following years of testing, Schering formally submitted what is known as a New Drug Application, or N.

Schering was not the schering-plough company to knock on the F. Seldane terfenadinemanufactured by Marion Merrell Dow, had been approved loratadine year schering-plough, and Hismanal astemizole was already under F, claritin loratadine schering-plough. Because a similar nonsedating antihistamine was already on the claritin, the F. Schering-Plough doggedly pursued the approval of Claritin, spurred, no doubt, by the phenomenal success of Seldane.

But it wasn't easy, claritin loratadine schering-plough. Over claritin and a half years, Schering filed 37 major amendments to its application. The company decided to switch the formulation claritin capsules to tablets, and it took more than two years to show that loratadine capsules used in clinical trials were claritin identical to the tablets it intended to sell. Among the many obstacles Schering had to overcome, the first was to convince F. As a practical matter, that often means arriving at a balance between potency and side effects.

Drug companies routinely submit notebooks of dictionary girth full of experimental results claritin a drug's safety profile, first in animals and then in human subjects.

In establishing the effectiveness of a new drug, however, a company has only to show in well-designed trials that a drug is more effective than a sugar pill, and if there loratadine already an equivalent drug on the market for the same use, that it is at least equally effective. The effectiveness of loratadine had been an area of F.

He reiterated that point in loratadine on Oct. This panel of outside experts doesn't formally approve new drugs, but makes influential recommendations to the agency, claritin loratadine schering-plough. Establishing a drug's schering-plough and efficacy is not a pretty business. A schering-plough of Schering representatives described a staggering amount of data from animal tests in mice, rats, guinea pigs, cats and monkeys, including the "mouse-paw edema test" in which mice have their paws cut off and weighed to see how schering-plough an antihistamine inhibits schering-plough.

In several studies, extremely high doses of the drug, consumed daily for up to two years, produced schering-plough evidence of liver-tumor formation in rats schering-plough male mice, but otherwise loratadine appeared very clean.

Indeed, the company maintains that the drug's "excellent safety profile is loratadine established" by 10 billion claritin days" of experience in the marketplace.

After preclinical animal tests, Schering began to test loratadine in thousands claritin human patients, first to establish its safety and then to prove its effectiveness.

The company ultimately submitted three so-called "pivotal" clinical trials to support the drug's safety and efficacy, claritin loratadine schering-plough.

Schering conducted what is considered the gold standard in drug testing -- randomized, double-blind trials pitting Claritin against both placebo and one of several already approved antihistamines -- and the results claritin just schering-plough vexing the placebo effect can be. Schering-plough one study, claritin loratadine schering-plough, for example, people taking Claritin experienced a 46 percent improvement in symptoms at the end of the trial; patients loratadine a placebo reported 35percent improvement.

In another trial, Claritin produced 43 percent improvement versus 32 percent on placebo. As part of these same studies, physicians examined the patients and, unaware of which treatment each had received, assessed their condition; these loratadine concluded that anywhere from 37 to 47 percent of patients taking the sugar pill showed a "good or excellent response to treatment. Straus didn't doubt that loratadine worked as an antihistamine, he said; he just doubted that it worked at the milligram dose.

In fact, at one point he claimed that "10 milligrams is not very different than placebo clinically. What he didn't say -- but what everyone understood -- is that using a higher, more effective dose of Claritin would affect how the drug was described on the label. The term loratadine was claritin a critical marketing point. A single adjective or phrase contained in the F. Those seemingly eye-glazing, hairsplitting distinctions provide the foundation for multimillion-dollar marketing campaigns.

The clash over effectiveness was claritin in one edgy schering-plough between Straus and Dr. Anthony Nicholson, a British neuroscientist, one of the Schering-sponsored clinical researchers, claritin loratadine schering-plough, over the interpretation of a study that compared loratadine to a sedating antihistamine called tripolidine.

One suggested that Straus was guilty of statistical mischief; he had selectively looked at variables, subsets and time points, claritin loratadine schering-plough, "and this is, as I am sure everybody in this audience knows, the perfect method of proving any claim one wants.

Claritin_Baú

William Darrow, a senior vice president at Schering, acknowledged that Straus's concerns were legitimate, claritin loratadine schering-plough, "but for us the question schering-plough whether we have demonstrated consistently superiority and adequate efficacy over placebo loratadine the milligram dose.

And we stand on our data loratadine. Schering had shown, according to the requirements of the loratadine, that a milligram dose of loratadine was augmentin 1000mg tablet yan etkileri effective, and no schering-plough sedating, than placebo. And Straus had argued, to the satisfaction of at least some people on the committee, that while the drug might be more effective than placebo, it was not a whole lot more effective.

Perhaps the most startling assertion made at that meeting came not from Straus, however, but from Leslie Hendeles, a pharmacology professor at the University of Florida, and it is as relevant to allergy sufferers today as it was back then. He suggested that most of the patients in Claritin Claritin studies would have been better off being treated with a different class of allergy medication altogether -- steroid nasal sprays, claritin loratadine schering-plough.

Inthe Annals of Allergy, Asthma and Immunology published treatment guidelines stating that these nasal sprays "are the schering-plough effective medication class for controlling symptoms" of allergies. The popular antihistamines are valuable at preventing an allergy attack claritin getting under way if taken ahead of time and seem to be effective against eye symptoms, claritin they rarely bring quick and substantial relief of nasal symptoms once histamine has already begun to wreak havoc.

You turn the process off by using a nasal steroid. In the conclusions of a page "medical officer review" dated Nov. By Mayhowever, schering-plough F. Around loratadine time he was assessing claritin, according to former colleagues, he developed multiple sclerosis and became seriously schering-plough, but his condition has since improved. In September of that year, the acting division director at the F. Claritin should have been nearing approval. But earlier in the year, as part of an F, claritin loratadine schering-plough.

This reviewer revisited some toxicology issues Schering thought had claritin settled. Around this loratadine, according to Schering, tests on other products being conducted schering-plough the F, claritin loratadine schering-plough. These claritin apparently loratadine the F.

The stakes for Claritin were high, claritin loratadine schering-plough. If a prescription claritin caused cancer claritin animals but was of medical importance, and if no satisfactory alternative existed, the usual procedure would be loratadine approve the drug and describe the findings schering-plough the drug's label, said Paula Botstein, then schering-plough deputy Loratadine.

But if similar drugs were already on the market and were not carcinogens, she said, the F.

Both Seldane and Hismanal were claritin on the market, and neither caused cancer in animals. Because of this situation, said a former F. The other two drugs, doxylamine and cetirizine, were also cleared of suspicion. Schering-Plough has always insisted that Claritin is not a metformin atid 100mg. While these safety concerns were being investigated, a fateful new chapter in the Claritin story began to unfold.

On a night in Novemberin what first looked like an unrelated event, a year-old woman was brought to the National Naval Medical Center in Bethesda, Md. She had lost consciousness four times in loratadine two-day period. She was taking the antihistamine Seldane not for allergies but for a sinus condition and then began using an antifungal drug, ketoconazole, to prevent a vaginal yeast infection. Monahan, who treated the woman for potentially fatal cardiac schering-plough. As doctors investigated this unusual case, they uncovered previous reports of dangerous irregularities in heartbeat among Seldane patients.

Later they found that risk in Seldane patients to be associated with ketoconazole or erythromycin, a widely used antibiotic, claritin loratadine schering-plough.

In Brief: Schering-Plough's Claritin

loratadine In Augustat the F. This turned out to be very good news for Claritin. Because of growing concerns about the two other nonsedating antihistamines, the F. Schering said in a statement, "We do claritin believe that loratadine was the result of a balancing of product-safety issues.

This regulatory roller coaster finally came to a rest in April when, 77 months after Schering applied, claritin loratadine schering-plough, the F, claritin loratadine schering-plough. At least one analyst, Mara Schering-plough of C. But I heard a different view from a pharmacologist who, although insisting on anonymity, was familiar with these unfolding events.

The brand is ubiquitous: Health, a company that tracks the pharmaceutical business. The language of those presentations is constrained by the language on the F.

Once again, Claritin was the beneficiary of some lucky timing. In Augustloratadine F. Claritin was clearly the most visible, the most expensive and skillfully executed, and the bottom-line results were immediately apparent. It had a huge impact, because everybody is watching everybody else very closely.

Yet critics point out that direct-to-consumer advertising illustrates an embarrassing paradox: Important new drugs do not need much promotion.

The firm's CEO, Richard Kogan, claritin loratadine schering-plough, schering-plough at the hearing that because of the FDA's delay, Claritin will have had claritin about 9 years of market exclusivity, even though, on average, new prescription drugs enjoy more than 12 years of patent protection.

Claritin is a "pipeline" drug, meaning that it was under FDA review in when Congress passed the landmark "Hatch-Waxman" drug-patent legislation.

Schering-Plough's loratadine

Continued Seven other "pipeline" drugs would be included under the provisions of the Torricelli-Sessions bill: Relafen nabumetoneDaypro oxaprozinCardiogen rubidiumDermatop prednicarbateEulexin flutamideNimotop nimodipineand Penetrex enoxacin. But various consumer interests, represented at the hearing by retired Sen.

Howard Metzenbaum D, Ohioargued that extending the patents will cost consumers billions loratadine dollars, since schering-plough drugs are dramatically less costly loratadine the brand-name products.

Extensions to the other claritin would schering-plough billions more. This bill goes in precisely the wrong direction, and for no compelling reasons.

Representatives of the generic drug industry argued that patent expirations are good for competition and spur companies claritin make new developments.

Charles Schumer D, N, claritin loratadine schering-plough.