In those days, the subject of generics, you worry a lot, “afraid for our health, heads of government.” Generics are not sure, not helped, as brand names for your illness, etc. They are manufactured in facilities unautorised. Is this true or is it just an attempt, some U.S. pharmaceutical companies and pharmacy benefit.
Drugs are sold in the United States approved by the FDA, if they are a brand or generic. “Most people believe that if more something costs, it must be better quality. In the case of generics, this is not true,” said Gary Buehler, director of the FDA office of generic drugs . “Quality standards are the same brand and generic drugs.
Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. The FDA approval must obtain a generic drug:
* Contains the same active ingredients as the innovator drug (excipients may vary)
* If, in the same strength, dosage form and route of administration
* Have the same use indications
* Bioequivalent
* The same batch of identity, strength, purity, justice to the quality and
* Are required manufactured under the same strict standards of good manufacturing practice, the FDA for the practice of innovative products
So we can conclude that: the generic drug is a drug that is a brand-name drugs bioequivalent with respect to pharmacokinetic and pharmacodynamic properties. Generika Wirkstoff müssen den gleichen in der gleichen wie die Stärke “Neuer” Marke und enthalten bioäquivalent erforderlich sind, um den gleichen Anforderungen of Arzneibuch für die Vorbereitung zu treffen. By extension, therefore, generics are the dose, strength, route of administration, the same safety and efficacy and intended use.
Thus, in some cases, the product of “normal” makes the brand product, but in another area.
The main reason for the reduced cost of generic drugs is that those with smaller pharmaceutical companies that do not invest in research and development are not manufactured into new drugs. The main research and development by large pharmaceutical companies to develop a new drug to market is often cited as a reason for the high cost of new agents – they want those costs incurred before the patent is the result of expires.Other High prices indicate that each year billions of pharmaceutical companies to market their products.
Quand une société pharmaceutique marchés d’abord un médicament, il est généralement possible par un brevet que seule la société pharmaceutique qui a développé la vente de drogue. This allows the company the cost of developing that particular drug to be recovered. It is often cost millions of dollars to develop a new drug before the test, it authorized the use. Once the patent expires on a drug, pharmaceutical companies will be able to produce and sell the drug. Because the drug has already been tested and approved, is simply the cost of drug manufacturing is a fraction of the cost of initial testing and development of this particular drug.
Thus, despite the strict standards established by the FDA for approval of generic drugs and to report their compliance with these standards, a number of misconceptions about generic drugs that we have to refute:
MYTH Generics take longer to act in the body.
REALITY: The company tries to sell a generic drug must show that the drug provides the same amount of active ingredient in the same period as the original product.
MYTH: Generics are not as powerful as brand name drugs.
FACT: FDA requires generics of the same quality, strength, purity and stability as brand name drugs.
MYTH: Generics are not as safe as brand name drugs.
FACT: FDA requires that all drugs are safe and effective and that its benefits outweigh the risks. Since generics contain the same active ingredients and work the same way in the body, they have the same risk profile as their brand similar benefits.
The drug companies MYTH: Brand-are made in modern production facilities, and generics are also made to plant standards.
FACT: FDA will not allow drugs to be in compliance with inferior equipment. The FDA conducts over 3,500 inspections annually to ensure that all businesses are met. Generic firms have facilities comparable to those of brand name company. In fact, business banking brand for about 50 per cent of the production of generic drugs. They are often copies of their own and other brands sell drugs, but without the trademark.
MYTH: Generics are likely to have more side effects.
FACT: There is no evidence. FDA monitors reports of adverse drug reactions and found no difference in rates between generic and brand name.
And finally, we can conclude is that the only “dangerous and unhealthy” thing about generics is the financial loss for large pharmaceutical companies who want to protect their monopoly on our health, despite the need for some low income households for effective medical care.
We believe that knowledge and understanding intelligent decisions on prescription drugs than we do. In today’s society we are bombarded with massive amounts of conflicting information about our health and medications that are available. In an effort for some of this confusion, we strive to provide as much information as possible about your health and prescription drug to clear.