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RegisterNaproxen ER FDA guidance [Regulatives / Guidelines]
Hi Helmut,
Thank you for sharing your thoughts on this topic. Coincidentally, I found a pending citizen petition related to BE criteria for Naprelan (extended release Naproxen). The petitioner did ask FDA to request partial AUCs. In checking the package insert, EC-Naprosyn (enteric coated Naproxen for delayed release) was not approved for acute pain as the release is delayed. I would like to know your opinion on this citizen petition.
http://www.regulations.gov/#!documentDetail;D=FDA-2014-P-0407-0001
Thanks,
Sunny
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan]
Thank you for sharing your thoughts on this topic. Coincidentally, I found a pending citizen petition related to BE criteria for Naprelan (extended release Naproxen). The petitioner did ask FDA to request partial AUCs. In checking the package insert, EC-Naprosyn (enteric coated Naproxen for delayed release) was not approved for acute pain as the release is delayed. I would like to know your opinion on this citizen petition.
http://www.regulations.gov/#!documentDetail;D=FDA-2014-P-0407-0001
Thanks,
Sunny
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan]
Complete thread:
- Naproxen ER FDA guidance lechia 2014-04-14 22:57 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Naproxen ER FDA guidance Helmut 2014-04-15 13:09
- Naproxen ER FDA guidance jag009 2014-04-15 15:36
- Naproxen ER FDA guidance lechia 2014-04-15 16:10
- Naproxen ER FDA guidance lechia 2014-04-24 16:49
- Naproxen ER FDA guidance sunny 2014-04-25 02:43
- Naproxen ER FDA guidance lechia 2014-04-24 16:49
- Naproxen ER FDA guidancesunny 2014-04-17 00:07
- Naproxen ER FDA guidance Helmut 2014-04-15 13:09
Ing. Helmut Schütz