We hear a lot today about the pros and cons of generic medications. the markets are flooded with these medications and the name brand companies warn the customers about using only name brand. The truth of the matter is that most generic brands in U.S. markets are just as good if not the same as their name brand counterparts. in order for readers to understand it is best to start with the defenition of what is a generic drug. A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are usually sold for much less in comparison to the branded ones. According to the Congressional Budget Office, generic drugs save american consumers an estimated $8 to $10 billion a year on the retail pharmacies level. For drugs to be sold in pharmacies an and stores in the U.S.A, Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. their are laws put into place for the protection of final consumers, one is The Hatch-Waxman Act of 1984, which made ANDAs possible by creating a compromise in the drug industry. due to this law Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process. New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's research and development by giving the company that develops it the right to be the only company that sells the drug while the patent is still in effect. When the patents right period of exclusivity expire, manufacturers admit an application to the Federal Drug Administration to sell generic versions of a particular brand name drug. The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness when the brand name drug was approved. This applies only to drugs first marketed after 1962. Health professionals and consumers must make sure that the generic version on the shelvs in their corner storesare FDA approved. this will be mentioned on the container the drug is in. Once they customers see the federal Drug Administratiions seal on the box they can be assured that iut is an FDA approved generic drugs and that it met the same rigid standards as the name brand drug. In order for a generic to gain FDA approval, a generic drug must: a) contain the same active ingredients as the innovator drug (inactive ingredients may vary) b) be identical in strength, dosage form, and route of administration c) have the same use indications d) be bioequivalent e) meet the same batch requirements for identity, strength, purity, and quality F) be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products. Generic medications are typically named for the active ingredients that they contain. for example the famous Viagra. Viagra is the brand name registered under the application of the innovater company pfizer. the generic name for the drug is Vardenafil HCl, for the ingredients contained in this perticular prescription pharmaceutical. another good example is Propecia and its generic counterpart Finasteride. In many cases the same company that manufactures the brand name drug will also produce the generic equivalent inorder for them to maintain a market share. Now that you have learned what is a gerneric medication, and what to look for before you make a pyrchase, you may go ahead and share you newly aquired knowledge with your friends, and hopefully save large sums of money in the process. |
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