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Post by itellthefuture777 on Oct 29, 2018 11:05:17 GMT -5
SUPPL-18
NDA#022472
NICE!
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Post by itellthefuture777 on Oct 29, 2018 11:07:53 GMT -5
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Post by itellthefuture777 on Oct 29, 2018 11:10:53 GMT -5
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Post by porkini on Oct 29, 2018 11:13:40 GMT -5
Thanks for the updates with link!  |
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Post by hellodolly on Oct 29, 2018 11:19:57 GMT -5
Cam I get a small taste to wet my appetite. My work computer says the site is filled with malware and adware and won't let me access it! TIA
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Post by peppy on Oct 29, 2018 11:30:44 GMT -5
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Post by xanet on Oct 29, 2018 12:09:54 GMT -5
Help me out here. I read through the information and found only very minor changes and nothing of obvious benefit. What am I missing?  |
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Post by peppy on Oct 29, 2018 12:12:22 GMT -5
Help me out here. I read through the information and found only very minor changes and nothing of obvious benefit. What am I missing? This “Changes Being Effected” supplemental new drug application provides for an addition to Section 6.2, Postmarketing Experience, of the Afrezza Prescribing Information (PI), informing of the risk for bronchospasm, and a revision to PI Section 5.5, Lung Cancer, to reflect a correction of the histopathological diagnosis of a case of lung cancer due to lung blastoma. Additional minor editorial revisions are also included in the PI, Medication Guide, and Instructions for Use. I see no benefit as well. |
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Post by agedhippie on Oct 29, 2018 12:14:01 GMT -5
Old: Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to AFREZZA and were reported by investigators after clinical trial completion. New: Two additional cases of lung cancer (squamous cell and lung blastoma) occurred in non-smokers exposed to AFREZZA and were reported by investigators after clinical trial completion. The 12 unit dose was added. Has anything else changed? |
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Post by agedhippie on Oct 29, 2018 12:19:03 GMT -5
Has anything else changed? Yes, I should have read all of Peppy's post before I replied Section 6.2 is new: The following adverse reactions have been identified during post approval use of AFREZZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: bronchospasm. |
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Post by peppy on Oct 29, 2018 12:36:54 GMT -5
Old: Two additional cases of lung cancer (squamous cell) occurred in non-smokers exposed to AFREZZA and were reported by investigators after clinical trial completion. New: Two additional cases of lung cancer (squamous cell and lung blastoma) occurred in non-smokers exposed to AFREZZA and were reported by investigators after clinical trial completion. The 12 unit dose was added. Has anything else changed? Novolog 155 deaths and 4,478 serious cases. what is your guess aged, death by heart attack? keto burgers?  |
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Post by agedhippie on Oct 29, 2018 12:50:38 GMT -5
Novolog 155 deaths and 4,478 serious cases. what is your guess aged, death by heart attack? keto burgers? The problem is that they are FAERS numbers and unless there is a gross discrepancy the FDA is not going to act on them for the reason given in the Afrezza section 6.2 - the difficulty in establish cause and effect, and getting a true reflection of frequency (since reporting is optional). All this tells you is that a number of people died while taking Novolog which is inevitable, what it doesn't say is if the deaths were Novolog related. Once Afrezza has been out there for 20 years you will probably be looking at a lot of deaths flagged to Afrezza in the same way. |
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Post by peppy on Oct 29, 2018 12:58:07 GMT -5
Novolog 155 deaths and 4,478 serious cases. what is your guess aged, death by heart attack? keto burgers? The problem is that they are FAERS numbers and unless there is a gross discrepancy the FDA is not going to act on them for the reason given in the Afrezza section 6.2 - the difficulty in establish cause and effect, and getting a true reflection of frequency (since reporting is optional). All this tells you is that a number of people died while taking Novolog which is inevitable, what it doesn't say is if the deaths were Novolog related. Once Afrezza has been out there for 20 years you will probably be looking at a lot of deaths flagged to Afrezza in the same way. Ditto. did you see Mika was talking about a 30 year old she worked with that died of cancer? A neighbors 20 something daughter died of cancer here, 4 years ago, she wasn't a diabetic. Babies with brain cancer aged. 10 year old kids dying with blastomas. Have another hit, of fresh air. |
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Post by mnkdfann on Oct 29, 2018 14:02:43 GMT -5
Help me out here. I read through the information and found only very minor changes and nothing of obvious benefit. What am I missing? This “Changes Being Effected” supplemental new drug application provides for an addition to Section 6.2, Postmarketing Experience, of the Afrezza Prescribing Information (PI), informing of the risk for bronchospasm, and a revision to PI Section 5.5, Lung Cancer, to reflect a correction of the histopathological diagnosis of a case of lung cancer due to lung blastoma. Additional minor editorial revisions are also included in the PI, Medication Guide, and Instructions for Use. I see no benefit as well. So, not only no benefit, but actually a worse label for warnings than before? If so, why did the OP describe this as 'NICE!'? Are we missing something? |
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Post by peppy on Oct 29, 2018 14:10:38 GMT -5
This “Changes Being Effected” supplemental new drug application provides for an addition to Section 6.2, Postmarketing Experience, of the Afrezza Prescribing Information (PI), informing of the risk for bronchospasm, and a revision to PI Section 5.5, Lung Cancer, to reflect a correction of the histopathological diagnosis of a case of lung cancer due to lung blastoma. Additional minor editorial revisions are also included in the PI, Medication Guide, and Instructions for Use. I see no benefit as well. So, not only no benefit, but actually a worse label for warnings than before? If so, why did the OP describe this as 'NICE!'? Are we missing something? he made a mistake. hands off. |
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