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