Hello glenkanawati,
According to the U.S. Food and Drug Administration, generic drugs are
chemically identical and just as effective as brand name drugs.
??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.?
?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 .?
FDA
http://www.fda.gov/cder/ogd/
============================
Common questions and answers (Q&As) about generic drugs.
How does FDA ensure that my generic drug is as safe and effective as
the brand-name drug?
?All generic drugs are put through a rigorous, multi-step review
process that includes a review of scientific data on the generic
drug's ingredients and performance. FDA also conducts periodic
inspections of the manufacturing plant, and monitors drug quality ?
even after the generic drug has been approved.?
If generic drugs and brand-name drugs have the same active
ingredients, why do they look different?
?Generic drugs look different because certain inactive ingredients,
such as colors and flavorings, may be different. These ingredients do
not affect the performance, safety or effectiveness of the generic
drug. They look different because trademark laws in the U.S. do not
allow a generic drug to look exactly like other drugs already on the
market.?
Is my generic drug made by the same company that makes the brand-name drug?
?It is possible. Brand-name firms are responsible for manufacturing
approximately 50 percent of generic drugs.?
Are generic drugs always made in the same kind of facilities as brand-name drugs?
?Yes. All generic drug manufacturing facilities must meet FDA?s
standards of good manufacturing practices. FDA will not permit drugs
to be made in substandard facilities. FDA conducts about 3,500
inspections a year to ensure standards are met.FDA makes it tough to
become a generic drug in America so you can feel confident about
taking your generic drugs. ?
FDA
http://www.fda.gov/cder/consumerinfo/generic_info/generics_question_brochure.htm
============================
Are generics safe? And effective?
?Generics work just as quickly in the body as brand name drugs.
A generic drug manufacturer must prove to the FDA that its drug
delivers the same amount of active ingredients in the same time frame
as its brand name equivalent.
Generics are just as powerful as brand name drugs.
The FDA requires that a generic have the same quality and strength as
its brand name counterpart.
Generics are just as safe as brand name drugs.
The FDA requires that ALL drugs be safe and effective. Since generics
contain the same active ingredients as the brand, they are just as
safe and effective as their brand name equivalents.
Generics are made in FDA-inspected facilities.
The FDA conducts about 3,500 inspections a year on all pharmaceutical
facilities. Generics manufacturers? production facilities are subject
to the same FDA standards as brand name firms? facilities.
Generic drugs have NO ADDITIONAL side effects compared to brand name drugs.
The FDA monitors reports of adverse drug reactions and has found no
difference in side effects between generic and brand name drugs.?
?In the United States, trademark laws do not allow a generic drug to
look exactly like the brand name drug. Therefore, you can expect a
generic drug to be a different color or a different shape than its
brand name counterpart. However, the way it looks has no effect on how
the drug works.?
If you still have questions about drug safety or effectiveness, the
FDA has set up a toll-free hotline at 1-888-463-6332.
http://www.caremark.com/wps/portal/!ut/p/kcxml/04_Sj9SPykssy0xPLMnMz0vM0Y_QjzKLd4z38wXJmMUbxBub6keiijjCBXw98nNT9YP0vfUD9AtyQyPKHR0VAQuD3zc!/delta/base64xml/L0lDU0lKQ1RPN29na21DU1NTUSEhL29Cb1FBQUlRZ2pGSUFBUWhDRUlRakdFSnpoQkMvNEpGaUNvMGVoMWljb25RVkdoZC1zSVQzaTlVQS83X0FfMThSLzM!?PC_7_A_18R_docid=CMS-2-003528#P24_955
=========================================
I checked the PubMed medical database and found a number of studies
regarding the effectiveness of generics to brand name drugs.
?Fungizone and generic amphotericin B are similar in efficacy,
pharmacokinetics, and safety in the treatment of experimental IPA.?
[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15793161&query_hl=5&itool=pubmed_docsum
----------------
Are brand-name and generic warfarin interchangeable? Multiple n-of-1
randomized, crossover trials.
RESULTS:
?There were no differences between warfarin products in terms of mean
INR results or number of dosage adjustments required. There also was
no difference in INR variation based on warfarin formulation (p >
0.69), nor was a patient and warfarin interaction found (p > 0.81).
The INR results were not influenced by whether patients were
maintained on Coumadin only (control group) or interchanged between
Coumadin and generic warfarin (p = 0.98). CONCLUSIONS: It appears that
patients can safely and effectively switch between generic warfarin
and Coumadin.?
[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15914517&query_hl=5&itool=pubmed_docsum
----------------
Substitution of generic warfarin for Coumadin in an HMO setting
?Substitution of Barr warfarin for Coumadin did not significantly
affect INR control, warfarin management, or adverse events. Our
findings suggest that HMOs can safely substitute at least 1 generic
formulation of warfarin without extra monitoring.?
[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=11978149
----------------
Generic drugs in the treatment of epilepsy
AIM:
?We discuss some controversial aspects with prescription of generic
drugs (GD) and the problems concerning bioequivalence, mainly in the
case of drugs with non-linear pharmacokinetics and/or narrow
therapeutic rank, like the antiepileptic drugs (AED).?
CONCLUSION:
?The American Academy of Neurology and Epilepsy Foundation maintains
that the individual and physician should be notified and give their
consent before a switch in antiepileptic medications is made, whether
it involves generic substitution for brand name products, or generic
to generic substitutions.?
[PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=16317637
----------------
Therapeutic equivalency of generic antiepileptic drugs: results of a survey.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=15582850
----------------
The bioequivalence and therapeutic efficacy of generic versus
brand-name psychoactive drugs.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?itool=abstractplus&db=pubmed&cmd=Retrieve&dopt=abstractplus&list_uids=12860486
Search terms:
Generic versus brand name drugs
Effectiveness
FDA
PubMed
I hope the information provided is helpful!
Best regards,
Bobbie7 |
,
0 Comments
)