jag009
★★★

NJ,
2022-09-08 21:30
(617 d 12:19 ago)

Posting: # 23279
Views: 2,116
 

 strange question: An RLD (RS) which can be scored [Regulatives / Guidelines]

Hi all,

A strange question... for FDA (Or anywhere else), if a RS or RLD product is scorable (100 mg, scored into 2 50 mg), can one file an ANDA for a 50 mg generic by comparing 2x50 mg vs the scorable 100 mg reference? My initial guess is no but strange things do happen...

Any thought?

thx
john
dshah
★★  

India/United Kingdom,
2022-09-09 19:52
(616 d 13:56 ago)

@ jag009
Posting: # 23289
Views: 1,792
 

 strange question: An RLD (RS) which can be scored

Hi John!

It can be a 505(b)(2) application with consideration that 50 mg is effective and useful for patient.

Regards,
Divyen
wienui
★    

Germany/Oman,
2022-09-14 19:25
(611 d 14:24 ago)

(edited by wienui on 2022-09-15 12:09)
@ jag009
Posting: # 23294
Views: 1,609
 

 strange question: An RLD (RS) which can be scored

Hi John,

❝ A strange question... for FDA (Or anywhere else), if a RS or RLD product is scorable (100 mg, scored into 2 50 mg), can one file an ANDA for a 50 mg generic by comparing 2x50 mg vs the scorable 100 mg reference? My initial guess is no but strange things do happen...


Scientifically it is possible, and regulatory-wise, I didn't see any problem because, as you know, in BE, the dose of the test and reference drug formulation must be the same, which is applicable here.
Moreover, the guidelines asked for scored tablets to be tested through in vitro comparative dissolution against the whole tablets ( 2half vs the whole one); why not this also be applied in vivo?

Cheers,
Osama
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