Bioequivalence and Bioavailability Forum • Naproxen ER FDA guidance

Naproxen ER FDA guidance [Regulatives / Guidelines]

posted by lechia – C of U, 2014-04-24 18:49 (4444 d 02:25 ago) – Posting: # 12891
Views: 4,413

❝ 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.

For some reason I can't reply to sonny's post and had to reply to my own.

It's funny that they call it a citizen petition, because it's a petition of an interested party (the patent holder trying to protect their product from generic competition). The goal here is to make it harder for others to get bioequivalence with their product by requiring partial AUCs.

I guess anyone running a BE study for this product is advised in case the FDA is convinced by Almatica.

Complete thread:

Naproxen ER FDA guidance lechia 2014-04-14 22:57 [Regulatives / Guidelines]
- 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 guidancelechia 2014-04-24 16:49
      - Naproxen ER FDA guidance sunny 2014-04-25 02:43
  - Naproxen ER FDA guidance sunny 2014-04-17 00:07