Bioequivalence and Bioavailability Forum • Naproxen ER FDA guidance

Naproxen ER FDA guidance [Regulatives / Guidelines]

posted by sunny – 2014-04-17 02:07 (4452 d 13:11 ago) – Posting: # 12845
Views: 4,497
(edited on 2014-04-25 10:10)

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]

Complete thread:

Naproxen ER FDA guidance lechia 2014-04-14 22:57
- 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 guidancesunny 2014-04-17 00:07