Dear Dr. Avinash,Back to the Top
From your mail I understand that your 40 mg Omeprazole Capsule
formulation is bioequivalent with the innovator and you wanted to ask
the possibility of getting waiver on your dose proportional 20 mg
I have about 15 years of rich experiance in this field and I have
filed more than 20 NDA,S / ANDA'S.
In my opinion it is a clear case of biowaiver because
1. Your 20 mg formulation is dose proportional to 40 formulation
which is bioequivalent
2. The therapeutic index of omeprazole is very wide and as such is
having no safety concern.
All you need to do is to map the in vitro dissolution profile of your
20 mg formulation with 20 mg innovator's formulation and submit the
application to FDA for waiver.
I would like to know the status of your 20 mg ANDA.For further
enquiry or hepl I am available for consultation.
E. Mail : davidpa.at.rediffmail.com
Back to the Top
I beg to differ from your opinion or probably I have not updated
myself with the latest version.Omeprazole and enteric coating goes
hand in hand!!.Now ,going by the CFR 320.22(d)2(iv), criteria for
waiver of evidence of invivo bio. or bioequivalence, what I could
interpret is that based on your successful biostudy of the 40 mg
strength against the innovators 40 mg, you cannot claim waiver for
the dose proportional 20 mg strength as this provision doesn't apply
to enteric coated or controlled release dosage form.
If at all there is a change in FDA's stand on this issue I would
appreciate you to update me on the same.
Thanks and regards
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