August 16, 2007
Generic Zyprexa (Olanzapine) Moving Towards Approval in Europe
The European Medicines Agency (EMEA) has recently recommended approval of a generic version of Eli Lilly's schizophrenia treatment Zyprexa (olanzapine). Zyprexa is currently the worlds top selling schizophrenia medication, with global sales in excess of over $4.7 billion in 2006.
The EMEA's Committee that the European Commission approve the pharmaceutical company named Krka to produce and sell a generic version of Zyprexa (olanzapine).
It is said that Krka plans to market the product as 2.5-, 5-, 7.5-, 10-, 15- and 20-mg tablets, and 5-, 7.5-, 10-, 15- and 20-mg disintegrating tablets under the name Zalasta.
It is not yet known when this new generic version of olanzapine will become available - but it increasingly seems likely it will be in the next year to 18 months. Generic versions of medications are typically brought to market at a fraction of the cost of the branded medications.
Posted by szadmin at August 16, 2007 08:46 AM
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Hurray! The world needs generics. Major pharmaceutical corporations are among the most profitable corporations and the biggest contributors to George W. Bush. And they get what they pay for. The man Bush appointed as "AIDS Czar" (a truly ridiculous title) was the former C.E.O. of Abbot Labs. One of his last acts as C.E.O. was to quadruple the price of Ritonavir. Never forget that Bush's Medicare Senior's Rx Initiative FORBIDS the US Government to bargain for volume discounts when buying drugs. With your tax dollars the U.S. Govt, pays RETAIL. Now Bush says he'll veto the expansion of CHIP, the Children's Health Insurance Plan. The only people the Bush Administration wants to see on welfafre are corpoate executives and other multi-millionaires. What about the people? Screw 'em!
s Health
Posted by: D.M.S. at August 16, 2007 12:10 PM
I guess the price setting of the generic product will be such that most pharmacists will consider switching over to the generic, while keeping the price as high as possible.
Business in eastern Europe are not socialist anymore.
We'll see...
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The Certificate of Suitability (CoS) granted by the European Directorate for the Quality of Medicines (EDQM) is the highest quality standard in Europe. It confirms that an active substance complies with the standards of the European Pharmacopoeia. Krka has been awarded the EDQM Certificate of Suitability for a number of its active substances.
A medicine by Krka is equivalent to the respective original product. Its pharmaceutical equivalence is confirmed by in vitro dissolution tests and its therapeutic equivalence by in vivo bioequivalence studies. Both evaluation methods involve direct comparison between the Krka’s and the originator’s product.
The efficacy and safety of Krka’s pharmaceutical products are under continuous surveillance and confirmed in practice. Numerous clinical studies include preregistration (phase III), postmarketing (phase IV) and pharmacovigilance studies.
http://www.krka.biz/en/stroka/generika/
Posted by: freeZotic at August 17, 2007 01:17 AM
So despite 1.2 billion worth of claims and law suits against Eli Lilly for claims by 1000's of people because Zyprexa has caused diabetes i guess they can absorb that kind of loss and it has been deemed a good trade off.
Posted by: Salty Davis at August 17, 2007 05:14 AM
i need help..my brother is schizophrenic..he take this medicine..after a years he doesnt want to take any medicine now..we bring him to some mental institution here in the philippines..any one or any support group with heart please help me..i dont want to lose my brother..thank u and hoping for reply..
Posted by: Ruth B. Padit at September 2, 2007 11:22 AM
Zalasta was aproved in europe by Emea and will be market probably beginning in 2008. In USA lily patent on zyprexa expires in April 2011.
Posted by: claudiuiosub at November 28, 2007 06:34 AM
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Hurray! The world needs generics. Major pharmaceutical corporations are among the most profitable corporations and the biggest contributors to George W. Bush. And they get what they pay for. The man Bush appointed as "AIDS Czar" (a truly ridiculous title) was the former C.E.O. of Abbot Labs. One of his last acts as C.E.O. was to quadruple the price of Ritonavir. Never forget that Bush's Medicare Senior's Rx Initiative FORBIDS the US Government to bargain for volume discounts when buying drugs. With your tax dollars the U.S. Govt, pays RETAIL. Now Bush says he'll veto the expansion of CHIP, the Children's Health Insurance Plan. The only people the Bush Administration wants to see on welfafre are corpoate executives and other multi-millionaires. What about the people? Screw 'em!
s Health
Posted by: D.M.S. at August 16, 2007 12:10 PM
I guess the price setting of the generic product will be such that most pharmacists will consider switching over to the generic, while keeping the price as high as possible.
Business in eastern Europe are not socialist anymore.
We'll see...
----------------------
The Certificate of Suitability (CoS) granted by the European Directorate for the Quality of Medicines (EDQM) is the highest quality standard in Europe. It confirms that an active substance complies with the standards of the European Pharmacopoeia. Krka has been awarded the EDQM Certificate of Suitability for a number of its active substances.
A medicine by Krka is equivalent to the respective original product. Its pharmaceutical equivalence is confirmed by in vitro dissolution tests and its therapeutic equivalence by in vivo bioequivalence studies. Both evaluation methods involve direct comparison between the Krka’s and the originator’s product.
The efficacy and safety of Krka’s pharmaceutical products are under continuous surveillance and confirmed in practice. Numerous clinical studies include preregistration (phase III), postmarketing (phase IV) and pharmacovigilance studies.
http://www.krka.biz/en/stroka/generika/
Posted by: freeZotic at August 17, 2007 01:17 AM
So despite 1.2 billion worth of claims and law suits against Eli Lilly for claims by 1000's of people because Zyprexa has caused diabetes i guess they can absorb that kind of loss and it has been deemed a good trade off.
Posted by: Salty Davis at August 17, 2007 05:14 AM
i need help..my brother is schizophrenic..he take this medicine..after a years he doesnt want to take any medicine now..we bring him to some mental institution here in the philippines..any one or any support group with heart please help me..i dont want to lose my brother..thank u and hoping for reply..
Posted by: Ruth B. Padit at September 2, 2007 11:22 AM
Zalasta was aproved in europe by Emea and will be market probably beginning in 2008. In USA lily patent on zyprexa expires in April 2011.
Posted by: claudiuiosub at November 28, 2007 06:34 AM