Biowaiver of Product with TE code AA [Regulatives / Guidelines]

posted by rajibkumar – 2018-04-18 05:37  – Posting: # 18695
Views: 811

Dear Members,

We are going to submit an ANDA of XXXX Tablet (375 mg, 500 mg & 750 mg Tablet). There will be a two separate ANDA for this molecule. One is for 500 mg Tablet & another one is for 375 mg & 750 mg Tablet.

For 375 mg & 750 mg Tablet, it would be a dose proportionate formula & formulation is slightly different (one excipient is changed) than the 500 mg Tablet.

According to Orange book, XXXX 500 mg tablet has been categorized TE code as AA. But for other two strength, they didn't say anything about the TE code & also there is no product-specific bioequivalence recommendation of this molecule.

Our plan is to claim biowaiver of all strength as it is designated TE code as AA & it also meets an appropriate in vitro dissolution standard which we assume will be acceptable to the Agency in order to be approved.

My question is, should we claim biowaiver of all of these three strengths considering TE code as AA or additionally is it required to conduct any study? Please note that the molecule is BCS class II drug.

Thanks in advance for kind cooperation.


Thanks & Best regards

Rajib

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