# Novartis is appealing FDA "not approvable" letter



## Jeffrey Roberts (Apr 15, 1987)

http://biz.yahoo.com/prnews/010816/nyth027.html ..."In June, the FDA issued a 'not-approvable' letter for Zelnorm/Zelmac(constipation predominant irritable bowel syndrome) requesting furtherinformation. *The company is submitting an appeal to the FDA regardingthe decision.* The application for regulatory approval was withdrawn inEurope. Subsequent to these decisions, Novartis and Bristol Myers Squibbhave mutually decided not to pursue the collaboration established todevelop and commercialize tegaserod (Zelmac/Zelnorm). Novartis recentlylaunched Zelmac in its first market, Mexico."[This message has been edited by Jeffrey Roberts (edited 08-16-2001).]


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## bellyknot (Jul 24, 2000)

Jeff,How long does an appeal usually take? Is it like with criminal court cases...up to 10 yrs or more? I hope not. The Zelmac is working for me.


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## Guest (Aug 17, 2001)

the zelnorm action group might want to consider sending letters in support of this appeal? If it has been submitted there it should be available for comment?tom


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## Guest (Aug 17, 2001)

Thanks Jeff for the update! I talked to Kate King, Associate Director of Communications for Novartis, and she also told me this morning that they filed an appeal. THIS IS BIG NEWS THAT PROVIDES A WINDOW OF OPPORTUNITY FOR ALL OF US TO APPLY THE PRESSURE TO THE FDA!!! SHE ENCOURAGES ALL OF US TO WRITE LETTERS TO THE FDA NOW! ESPECIALLY TO BERNARD SCHWETZ at bschwetz###oc.fda.gov and be sure to copy the letters to her at kate.king###pharma.novartis.com. She also suggested that we write to our congress(wo)men NOW! I also called my gastro and HE IS WRITING A LETTER TO ALL THE EMAIL ADDRESSES FOR THE FDA PEOPLE THAT YOU PROVIDED (at Zelnorm action group)! GET YOUR GASTROS IN ON THIS TOO! LET'S APPLY THE HEATING PAD TO THIER BELLIES INSTEAD OF OURS! REMEMBER THAT THE FDA PEOPLE ARE HUMAN TOO (?) SO WHEN YOU WRITE YOUR LETTERS...LET THEM FEEEEEL YOUR PAIN!!!! I'M SICK OF BEING SICK... SO I'M GETTING ON THE STICK!!!


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## Guest (Aug 18, 2001)

Chloe, You might want to join the zelnorm action group if you've got a contact at novartis.tom


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## Guest (Aug 18, 2001)

Tom,I don't know what is takes to join. I need to pursue it though, if I can contribute anything! Cloe


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## Guest (Aug 18, 2001)

clock on the link on the left above to zelnormaction group and it should give directionstom


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## Guest (Aug 18, 2001)

chloe, do you have an email address for Kate King?tom


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## Jeffrey Roberts (Apr 15, 1987)

Cloe indicated Kate's email address is kate.king###pharma.novartis.com.Kate and Novartis are well aware of the plight of the sufferers who would like access to Zelnorm. I believe it best to just Cc: her and Novartis on letters to the FDA and congress.I just want to say that because the situation with Zelnorm is quite different than Lotronex. In that case GlaxoSmithKline continues to be unwilling to work with the sufferer or the FDA to provide access to Lotronex. Novartis is committed to helping the sufferer. They continue to provide compassionate access to Zelnorm during this process of "approval" by the FDA. Unlike our email to GSK I believe we should be very supportive of Novartis' position.Jeff


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## Guest (Aug 19, 2001)

right, jeff. I feel there is a world of difference in the responsiveness of novartis and GSK.tom


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## Guest (Aug 20, 2001)

Tom, Jeff, who is GSK?


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## Jeffrey Roberts (Apr 15, 1987)

GSK is GlaxoSmithKline. They manufacture Lotronex.


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