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Dear Friends
Could somebody enlighten me as to how a Generic drug can be classified
as a Refence Listed Drug?
Thanks
Manish Chawla
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Dr Chawla,
About this specific issue, I know that a generic drug can be classified
as a reference (Listed Drug) if the REFERENCE is removed of the market.
This generic was the first one to be registered based on this REFERENCE.
Regards,
Daniel R. Campos
Brazil
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Dear Dr. Campos
Thanks for the reply. Under what cicumstances can we have a Generic
product replace a RLD as the new reference evethough both, the Generic
and the RLD (first) are commercially available.
Regards
Manish Chawla
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Dr. Chawla,
When a generic product is the reference, the REFERENCE product (RLD)
has not been commercially available. So, only the generic product is on
the market.
Regards,
Daniel
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Dear Dr. Chawla,
I think when Reference product is not available in the market, then
only you can treat a generic product as a RLD. But still every
regulatory authority has their own list for RLD e.g. Brazil (ANVISA)
has a list of RLD for the product to be registered in Brazil. In this
regard I fully agree with Dr. Campos. But before going ahead with your
project it is advisable to find out the RLD for that particular
regulatory authority.
Dr. Nirav Gandhi
Dear Manish,Back to the Top
When the innovator product is discontinued or withdrawn from the
markets voluntarily, the next first generic authorised by FDA gets the
RLD status.You can see many such generic products having RLD status in
orange book viz Cefixime (LUPIN),Fenofibrate (TEVA) and Fluoxetine
(ALPHAPHARM).
Kind regards,
Pradeep Bhadauria
Ranbaxy Research Laboratories.
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Dear Pradeep,
I was wondering what happens if there is no generic equivalent, and
innovator withdraws from the market (for reasons other than
safety/efficacy) and one is in the process of developing a generic
equivalent. What should be used as reference for BE study? Any
comments?
Sunil
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Dear Sunil,
I would think in this way, you don't have a Innovator in market you
don't have a first generic in the market now you are planning to have a
Generic Product fro the withdrawn product then in that case I think it
would be a case where you may have to buy the product from Innovator
and develop as a Supplemental NDA or Supplemental ANDA and file to FDA
with PAS or with CBE30, in that case you may or may not have to do BE
based on the regulatory and analytical data that you are generating for
the same.
Please correct me if I am wrong.
Regards
ATUL
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