505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ [Design Issues]

posted by Brus – Spain, 2021-01-25 16:56 (264 d 13:50 ago) – Posting: # 22188
Views: 771

Hi Helmut,

» So far so good. Since you are mentioning RLD you are targeting the FDA, right?

I called reference product as RLD, but it is not for FDA, it is for EMA. Sorry for the misunderstanding


» Is a single (not daily) 150 mg dose approved?

Yes. According SmPC of reference product, it is possible to administer one single dose of 150 mg.

» In Europe that’s the hybrid pathway. Additionally to this study generally clinical studies are required as well.

Why? If efficacy has indeed been demonstrated with 150 mg and SmPC establishes a 150 mg dose regimen. What more can you ask for? To my understanding, you just have to show that your 150 mg provided in your tablet will behave in the same way as the 150 mg of the reference product provided by a 100 mg tablet and a 50 mg tablet. What am I missing?

Best regards,

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