Bioequivalence and Bioavailability Forum • BE using non RLD

BE using non RLD [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2013-08-05 12:44 (4707 d 21:23 ago) – Posting: # 11198
Views: 6,339

Hi lb,

❝ Done that (submitted an ANDA with a BE on non RLD lower strength) for a highly variable statin and also got approval (along with bio-waiver for all the proportional lower strengths).

Sounds very fishy to me. I think it would render the FDA liable if the originator sues the FDA as a means of brand protection. Was this one of the cases where an originator RLD was not available, perhaps?

—
Pass or fail!
ElMaestro

Complete thread:

BE using non RLD zheng791 2013-08-03 21:45
- BE using non RLD ElMaestro 2013-08-03 22:17
  - BE using non RLD jag009 2013-08-03 22:51
    - BE using non RLD zheng791 2013-08-03 23:55
      - BE using non RLD jag009 2013-08-04 20:20
        
        BE using non RLD luvblooms 2013-08-05 05:57
        
        BE using non RLDElMaestro 2013-08-05 10:44
        
        BE using non RLD luvblooms 2013-08-05 13:46
        
        BE using non RLD ElMaestro 2013-08-05 13:59
        
        BE using non RLD luvblooms 2013-08-05 14:31
        
        BE using non RLD ElMaestro 2013-08-05 15:04
        Very strange! jag009 2013-08-05 16:02
        
        Very strange! Helmut 2013-08-05 16:37
        
        Very strange! jag009 2013-08-05 16:45
        
        Very strange! luvblooms 2013-08-05 17:30
        
        Very strange! jag009 2013-08-05 17:52