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Which FDA indicates about generic drugs?
Author: internet Published date: 2009-05-16

Answers of FDA for questions frequently put about generic drugs like

Which are generic drugs?
A generic drug is a copy which is identical like dopes name of mark of the proportioning, safety, force, how it is taken, of quality, the execution and the envisaged use.

The safe of generic drugs also that the name of mark are drugs?
Yes. The FDA requires that all drugs be sure and effective. Since generic medicines employ the same active substances and are shown to function the same manner in the body, they have the same risks and advantages that their counterparts of name of mark.

Are generic drugs as strong as the name of mark drugs?
Yes. The FDA requires generic drugs to have same quality, forces, purity and stability that drugs of name of mark.

Do generic drugs take longer with work in the body?
Number generic drugs function in the same way and in same amount of time like drugs of name of mark.

Why generic drugs are less expensive?
Generic drugs are less expensive because the generic manufacturers put 't have the loads of placement of the realizer of a new drug. New drugs are developed under the protection of patent. The patent protects the research, the development, marketing, and the promotionby investmentincluding giving to the company the right of sole to sell drug while it is in force. Like patents close to expiry, the manufacturers can apply to the FDA to sell generic versions. Since these manufacturers put 't have the same development costs, they can sell their product with the discounts substantial. Also, once generic drugs are approved, there is a greater competition, which reduces the price. Today, almost half of all the regulations are filled of generic drugs.

Are drugs of name of mark made in equipment more modern than generic drugs?
Number. The equipment of name of mark and generic drug must meet the same standards of good practices as regards manufacture. The FDA gained 'drugs of alluvium of T to be made in the lower equipment. The FDA leads approximately 3.500 inspections per year to make sure that standards are answered. The generic companies have equipment comparable with those of the companies of name of mark. In fact, companies of name of mark are related to 50 percent approximately of production of generic drug. They frequently draw from the copies of their clean or other drugs of name of mark but sell them without name of mark.

If the name of mark dopes and generic drugs have the same active substances, why do they seem different?
The United States, the laws of registered trademark do not make it possible a generic drug to look at exactly as the drug of name of mark. However, a generic drug must reproduce the active substance. The colors, savours, and some other inactive ingredients can be different.

Does each drug of name of mark have the generic counterparts?
Number Of drugs of name of mark are generally given the protection of patent during 20 years against the date of the tender of the patent. This ensures protection for the innovator who presented the initial costs (research including, development, and expenditure of sale) to develop new drug. However, when the patent expires, other pharmaceutical companies can present competing generic versions, but only after they were completely examined by the manufacturer and were approved by the FDA.

Which is the best information source on generic drugs?
Contact your doctor, pharmacist, or insurance company for information on your generic drugs. You can also visit the Web site of FDA at http://www.fda.gov/cder/ogd/index.htm for more information.

Which is generic initiative for the value and effectiveness (GIVE)?
On October 4, 2007, the FDA launched the generic initiative for the value and the effectiveness, or GIVES. The initiative will employ the supplys in hand to help the FDA to modernize and rationalize the process of generic approval of drug.

 



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