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Re: SPA rescission guidance Thanks for your reply and for the link to the ANCHOR CRL. I may be misreading the CRL, but I cannot find where it says the indication sought in the label included reduction of CV risk. Would appreciate your pointing it out. I interpret the letter, on page one, to state what the indication sought in the label was: This “Prior Approval” efficacy sNDA provides for the following indication: “as an adjunct to diet and in combination with a statin to reduce TG, non-HDL-C, Apo B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.” I believe the words "and CHD or a CHD risk equivalent" refer only to the patient population in the study, those with mixed dyslipidemia and CHD or a CHD risk equivalent. I read the expressed indication to be the reduction, when used as an adjunct to diet, and in combination with a statin, of TG and the other lipid parameters stated in that population Perhaps there is other language elsewhere stating that the indication sought in the label included CVD reduction, but I could not find it in a quick read. |
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Msg # | Subject | Author | Recs | Date Posted |
2168 | Re: SPA rescission guidance | ex_hacker202 | 0 | 5/18/2016 12:56:51 PM |