| According FDA (U.S. Food and Drug administration, to get FDA approval, a generic medication must: contain identical active ingredients as the innovator drug (inactive ingredients may differ), be identical in efficacy, dosage form and route of administration; have the same use indications, be bioequivalent; comply with the same batch requirements for identity, efficacy, purity and quality; be produced under the same rigid standards of FDA's good producing practice regulations required for brand name products. In other words, their pharmacological effects are identical to those of their branded versions.
A lot of people express doubts about the potency of generic drugs, since the latter are often considerably cheaper than brand name versions. They would like to know if the quality and efficacy have been compromised to manufacture inexpensive products. Generic medications are required to be as secure and effective as brand name drugs.
Actually, generic medications are cheaper, as the producers do not have to spend money on developing and marketing of a new drug. When a producer introduces a new medication to the market, the business has already spent a considerable amount of money on scientific research, development, marketing and promotion of the drug. The company that develops the medication is granted a patent - an exclusive right to sell the medication as long as the patent is in force. As the expiration date of the patent nears, producers can ask the FDA for a permit to make and sell generic versions of the drug. Without the startup costs for scientific research and manufacturing of the drug, firms can afford to make and sell it at a lower price. When several producers begin producing and selling a drug, the competition among them can also drive the price down.
The FDA applies the same standards for all medication manufacturing facilities a lot of firms make both brand name and generic medications. In fact, half of generic medication manufacture is made by bra ... |
