Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines. Any generic medicine must perform the same in the body as the brand-name medicine. It must be the same as a brand-name medicine in dosage, form and route of administration, safety, effectiveness, strength, and labeling with certain limited exceptions.
It must also meet the same high standards of quality and manufacturing as the brand-name product, and it must be and quality, taken and used in the same way as well. This standard applies to all generic medicines. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines.
The FDA Generic Drugs Program conducts a rigorous review to ensure generic medicines meet these standards, in addition to conducting inspections of manufacturing plants and monitoring drug safety after the generic medicine has been approved and brought to market. A generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients.
It is important to note that there will always be a slight, but not medically significant, level of expected variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted.
FDA limits how much variability is acceptable. For example, a very large research study 1 comparing generics with brand-name medicines, found that there were very small differences approximately 3.
You can also tell the difference by the name. The generic name is also the active ingredient, like the sedative diazepam for the brand Valium. Some medications are only available as a brand. But if a medication has a generic version, many states have laws that require pharmacists to switch to a generic when one is available. Keep in mind though, if you have insurance, only the cost of the generic medication may be covered.
Most insurance companies have drug formularies or lists of approved medications. Generic medications are just as safe as brands. They must go through the same testing to show they work before approval by FDA. Brand and generic medications have the same effects. This includes any side effects and adverse reactions. Your pharmacist can give you information on everything you need to know to take the medication safely. The inactive ingredients are fillers, binders, colors, flavors, and preservatives.
If you have a question about your generic medication, you can ask your pharmacist, or call the Poison Center at or go to PoisonHelp. Note: If you ever have an allergic reaction to a medication, call your doctor. If your symptoms are severe, call right away. Brand and generic medications must prove they are both safe and effective for FDA approval. If you choose to take a brand medication over a generic, your insurance may require you to pay full price.
Generics are the less expensive option in most cases. For certain medical conditions, your doctor may prefer sticking with a brand to keep your levels steady. Your pharmacist can answer any concerns you have about brand or generic medications. The FDA set a record last year for the number of approvals for new generic drugs. Experts say that should begin to reduce the price of prescription….
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Enrollment is open until January Lower prices generally go hand-in-hand with more competition. The results showed that Brand-name and generic drugs must contain the same active ingredient. However, characteristics of the drug not affecting the safety or efficacy may be different. This includes their appearance. United States trademark laws do not allow generic drugs to look exactly the same as the equivalent brand-name drugs.
However, the extent of these differences is regulated. Generic drugs can have different physical characteristics than their brand-name equivalents. The OGD developed a guidance document to help generic drug manufacturers produce drugs similar in shape and size to their branded counterparts. It provides parameters from both manufacturing and safety standpoints.
The FDA requires generic drugs to meet a number of standards before approval. These include:. The drug company must submit an ANDA, which is an abbreviated new drug application. It states that the generic drug meets each standard.
People taking a particular drug may want to know if there is a cheaper generic option. There are several ways to find out if there is a generic version of a brand-name drug:.
According to the OGD , all FDA-approved generic drugs must meet the same quality, purity, strength, and stability requirements as their brand-name counterparts. During a comparison study of U.
The conditions they looked at included hypertension, diabetes, osteoporosis, and psychiatric conditions such as anxiety and depression. However, another analysis found that generic drugs may not have the same clinical impact for cardiovascular conditions. A generic medicine is required to be the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken.
Generic medicines also have the same risks and benefits as their brand-name counterparts. The FDA Generic Drugs Program conducts a rigorous pre-approval review to make sure generic medicines meet these requirements. In addition, FDA conducts inspections of manufacturing plants, ensuring compliance with the agency's regulations on good manufacturing practices.
FDA staff monitor approved brand-name and generic drug products to make certain that medicines at all levels of the supply chain, from the active pharmaceutical ingredients that provide therapeutic effect, to the final products being sold to consumers, are safe, effective, and high-quality.
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