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Old 05-24-12, 12:56 AM
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Re: Anyone fill barr-teva lately?

You are correct Sarah, the placebo affect is the observable or felt improvement in health or behavior not attributable to a medication or treatment that has been administered. The Latin meaning of PLACEBO is "I shall please" which indicates that it is to refer to a positive experience associate with an inert substance or a fake procedure.

The FDA does allow a small percentage of variance in amount of active ingredient, I do not think that it is as high as 20% though. I do know for certain there are no regulations on the inactive ingredients. To be clear the "inactive ingredients" still could have affects on the performance of the drug in some people, but in general if the FDA approves a generic it works as close to the name brand drug as possible in the majority of people taking it.

The FDA does not seem to actually have a set standard of allowance of any discrepancy that I can find in research on this topic today, however studies have been done comparing the absorption of generics vs name brand drugs and have identified a 3.5% fluctuation in the absorption between them. [SOURCE: Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583-97.]

Below are some info I found searching the FDA website:

Originally Posted by fda FAQ
What standards do generic drugs have to meet?
Health professionals and consumers can be assured that FDA approved generic drugs have met the same rigid standards as the innovator drug. To gain FDA approval, a generic drug must:
  • contain the same active ingredients as the innovator drug(inactive ingredients may vary)
  • be identical in strength, dosage form, and route of administration
  • have the same use indications
  • be bioequivalent
  • meet the same batch requirements for identity, strength, purity, and quality
  • be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products SOURCE
Originally Posted by FDA Generic Drug standards Facts
FACT: FDA requires generic drugs to have the same quality and performance as brand name drugs.
  • When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, 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.
  • Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.
  • The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
  • Through review of bioequivalence data, FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release.
  • All generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs, and the generic products must meet the same exacting specifications as any brand name product. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products.
Another point I feel is important to bring up is that a medication that does not carry a trade name such as 'Amphetamine salts' not identified as a generic to adderall (not saying this applies specifically just using as an example) is not the same as a generic for a trade named medication. The addition or omission of certain inactive ingredients can and does affect the performance of a drug and can prevent it from performing as well as the trade named drug(such as adderall). There are regulations ensuring a drug claiming to be a generic of adderall behaves like adderall. There are no regulations that a drug not claiming to be a generic works as well as the trade named drug with similar active ingredients.

I feel this is important becuase there are a lot of Amphetamine salt drugs that ADHD patients receive, I think that we need to do additional research to see if these are all listed as official generics of adderall. This could be difficult becuase the document I quoted below indicates that drugs are sometimes mislabled as generics in databases so that insurance will pick up the cost under the coverage of generics. See Below:

Originally Posted by source PDF
The absence of a trade name does not equal a generic drug
Not all drugs marketed with out a trade name are approved generics. For example the drug product albuterol sulfate HFA, manufactured by IVAX, was approved without a proprietary name on Oct. 29, 2004, under NDA 21-457. Since the IVAX albuterol sulfate HFA product is labeled with only the established (generic) name, one could easily assume this is a generic version of one of the other two currently marketed albuterol sulfate HFA products: Proventil HFAand Ventolin HFA. Although all three products contain the same active ingredient and propellant (HFA), they are not substitutable products. Differences in excipients such as oleic acid and alcohol—in addition to actual differences in device components, such as the canister and size of valve—may affect performance, resulting in different clinical responses.

Confusion may also arise when drug products are listed incorrectly in drug databases. For example, First Data Bank and Medispan list IVAX albuterol sulfate HFAas a generic drug. Additionally, in clinical practice various
formularies may consider all three brand-name products as generics for reimbursement purposes. SOURCE
Additionally there is a WEALTH of information regarding generic drugs on the FDA site below:
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