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Biotech / Medical : IVAX Insider Trading -- Ignore unavailable to you. Want to Upgrade?


To: flickerful who wrote (360)12/28/1997 5:39:00 PM
From: 5,17,37,5,101,...  Read Replies (4) | Respond to of 756
 
This was on Deja News group: search ivax

Strange how these technical advancements occur at such moments. If this is true, Ivax's own monitoring program costs should be reduced.
Jackson

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Less frequent Clozaril Blood Testing near approval

Novartis's patent on Clozaril ran out, allowing others to introduce generic versions. Therefore, to increase sales, Novartis has applied to reduce the frequency of blood monitoring. In response, the FDA Advisory Panel in July recommended to reduce the blood draw frequency to every other week after a patient was stable on Clozaril for a period of 6 months.

As of right now, the FDA has not announced acceptance of this recommendation. I do not believe there is a hold up or any special concerns, rather they are working out the language of the changes with our company re: special patient considerations etc.

It is estimated that the changes will be in place by early 1998. The
advisory panel also recommended (by a majority vote, not unanimous) that the length be extended to monthly after 1 year of stable WBC's. The FDA "tabled" that idea for future review. Probably after evaluation of the twice monthly monitoring.