Posted by yxibow on November 14, 2006, at 3:56:25
In reply to Re: Brand Name vs. Generic Drugs » madeline, posted by Phillipa on November 12, 2006, at 23:21:05
> I know of two that are different one is synthroid, the other is klonopin. Love Phillipa
You are correct about some levothyroxine (Synthroid) preparations. They are rated BX by the 2006 FDA Orange book and require further evaluation. The notation of these acronyms follows in the boring drivel I included at the bottom.There are a few others including Synthroid I believe (not Klonopin) that have designations of "narrow therapeutic indexes" and the generics cannot either be varied at all from their produced milligrams, from what I gather, which includes warfarin (all generic, it is rat poison in a pill after all but the amount is important I know, my father has to take it and it is a blood monitored medication) and a few others.
The Orange Book, if one is really bored, is athttp://www.fda.gov/cder/orange/obannual.pdf
It is a 6+ MB Acrobat file.
We have beaten this with a dead horse and screaming baby seals. There is no reason to buy "brand name" Klonopin at exorbitant prices since it last expired in 1996, for reasons best known to Roche and the FDA since patents were 17 years and are now 20 years and Klonopin was patented in 1975, although a company can withdraw earlier (rarely do.).All the Klonopin generics are AB and are equivalent.
It is entirely possible that some people sensitive enough to a maximum (remember that is an absolute maximum) 20% difference in the AUC curve may experience a difference. The simplest thing is a dosage change. There is also the power of suggestion, that knowing taking a generic after a brand name drug can invoke a placebo effect, since, in the grand scheme of things, especially psychiatric medications, can have up to a 30% placebo effect, generic or not.
The price of brand Klonopin rises anywhere from 3-5x to 11x in quantity. Do you really want to support a pharmaceutical line (as genius as Leo Sternbach was, a Jewish scientist who worked at what is now Roche in Switzerland which allowed him to escape the Nazis and come to the US to live to a ripe old age and create Valium) that has had no new benzodiazepines come to market other than a patent extender on the last, Xanax XR?
I don't think I've ever been given a brand name benzodiazepine, but they have a few years on me...
I've always gotten random Mylan (they had a scandal of their own a while back about buying up raw materials and cornering the generic market) and Teva and other scored round random colored pills.
And now follows the boring FDA drivel in section 1.8--------------
The Orange Book says regards to generics:"
1.7 Therapeutic Equivalence Evaluations Codes
The coding system for therapeutic equivalence evaluations is constructedto allow users to determine quickly whether the Agency has evaluated aparticular approved product as therapeutically equivalent to otherpharmaceutically equivalent products (first letter) and to provide additionalinformation on the basis of FDA's evaluations (second letter). With few exceptions, the therapeutic equivalence evaluation date is the same as theapproval date.
The two basic categories into which multisource drugs have been placed areindicated by the first letter as follows:
A Drug products that FDA considers to be therapeutically equivalent to other pharmaceutically equivalent products, i.e., drug products for which:
(1)
there are no known or suspected bioequivalence problems. These are designated AA, AN, AO, AP, or AT, depending on the dosage form; or
(2)
actual or potential bioequivalence problems have been resolved withadequate in vivo and/or in vitro evidence supportingbioequivalence. These are designated AB.
B Drug products that FDA at this time, considers not to be
therapeutically equivalent to other pharmaceutically equivalent products,
i.e.,
drug products for which actual or potential bioequivalence problems
have not been resolved by adequate evidence of bioequivalence. Often
the problem is with specific dosage forms rather than with the active
ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX,
or B*."
------------------------
-- Jay
poster:yxibow
thread:702989
URL: http://www.dr-bob.org/babble/20061110/msgs/703340.html