Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,
If I want to submit an ANDA which has identical CMC information (same API, formulation, manufacturing site, process, equipment, container closure...) to an approved NDA  and the ANDA applicant is the NDA owner, is it allowed? I could not find law/guidance says I cannot. I know 505b2 does not allow to do it. In addition, the ANDA product specific guidance requests PD study (not BE). Scientifically, I think the PD study could be waived since nothing change. But anyone has the suggestion or experience for such kind of submission? 

Thank you

What is the change that lead to move from NDA to ANDA, as nothing change as you mentioned?

------------------------------
Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
------------------------------

Original Message:
Sent: 25-Jun-2018 11:42
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

Hi,
If I want to submit an ANDA which has identical CMC information (same API, formulation, manufacturing site, process, equipment, container closure...) to an approved NDA  and the ANDA applicant is the NDA owner, is it allowed? I could not find law/guidance says I cannot. I know 505b2 does not allow to do it. In addition, the ANDA product specific guidance requests PD study (not BE). Scientifically, I think the PD study could be waived since nothing change. But anyone has the suggestion or experience for such kind of submission?

Thank you

This message was posted by a user wishing to remain anonymous

Hi Gaurang,
Thanks for reply. Nothing will be changed as per CMC, the same API manufacturer, same DP manufacturer, same formulation, container closure... The change from NDA to ANDA is for financial reason, not for any other changes made to the DS and DP.

Thank you very much
Original Message:
Sent: 25-Jun-2018 13:48
From: Gaurang Bhavsar
Subject: ANDA refers to NDA

What is the change that lead to move from NDA to ANDA, as nothing change as you mentioned?

------------------------------
Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA

Original Message:
Sent: 25-Jun-2018 11:42
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

Hi,
If I want to submit an ANDA which has identical CMC information (same API, formulation, manufacturing site, process, equipment, container closure...) to an approved NDA  and the ANDA applicant is the NDA owner, is it allowed? I could not find law/guidance says I cannot. I know 505b2 does not allow to do it. In addition, the ANDA product specific guidance requests PD study (not BE). Scientifically, I think the PD study could be waived since nothing change. But anyone has the suggestion or experience for such kind of submission?

Thank you

This message was posted by a user wishing to remain anonymous

"ANDA applicant is the NDA owner, is it allowed?"

YES! The brand name big companies do this all the time! Please read and learn about authorized generic ANDA as a start.
Original Message:
Sent: 25-Jun-2018 11:42
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

Hi,
If I want to submit an ANDA which has identical CMC information (same API, formulation, manufacturing site, process, equipment, container closure...) to an approved NDA  and the ANDA applicant is the NDA owner, is it allowed? I could not find law/guidance says I cannot. I know 505b2 does not allow to do it. In addition, the ANDA product specific guidance requests PD study (not BE). Scientifically, I think the PD study could be waived since nothing change. But anyone has the suggestion or experience for such kind of submission?

Thank you

This message was posted by a user wishing to remain anonymous

I am not talking about Authorized Generic. I am talking about real ANDA. AG is still under PDUFA. This product is AG already, but we want to convert to real ANDA.
Original Message:
Sent: 25-Jun-2018 21:47
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

"ANDA applicant is the NDA owner, is it allowed?"

YES! The brand name big companies do this all the time! Please read and learn about authorized generic ANDA as a start.
Original Message:
Sent: 25-Jun-2018 11:42
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

Hi,
If I want to submit an ANDA which has identical CMC information (same API, formulation, manufacturing site, process, equipment, container closure...) to an approved NDA  and the ANDA applicant is the NDA owner, is it allowed? I could not find law/guidance says I cannot. I know 505b2 does not allow to do it. In addition, the ANDA product specific guidance requests PD study (not BE). Scientifically, I think the PD study could be waived since nothing change. But anyone has the suggestion or experience for such kind of submission?

Thank you

This message was posted by a user wishing to remain anonymous

From what I understand, you already have an approved NDA and wish to now market it (i.e. same NDA) as generic via ANDA? Yes, you can do it without prior approval but requires administrative notification. Big companies who had both branded and generic divisions do this all the time once the patent expires in addition to granting AG to another company!
Original Message:
Sent: 26-Jun-2018 10:51
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

I am not talking about Authorized Generic. I am talking about real ANDA. AG is still under PDUFA. This product is AG already, but we want to convert to real ANDA.
Original Message:
Sent: 25-Jun-2018 21:47
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

"ANDA applicant is the NDA owner, is it allowed?"

YES! The brand name big companies do this all the time! Please read and learn about authorized generic ANDA as a start.
Original Message:
Sent: 25-Jun-2018 11:42
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

Hi,
If I want to submit an ANDA which has identical CMC information (same API, formulation, manufacturing site, process, equipment, container closure...) to an approved NDA  and the ANDA applicant is the NDA owner, is it allowed? I could not find law/guidance says I cannot. I know 505b2 does not allow to do it. In addition, the ANDA product specific guidance requests PD study (not BE). Scientifically, I think the PD study could be waived since nothing change. But anyone has the suggestion or experience for such kind of submission?

Thank you

#6's reply is correct.  You should not need an ANDA (and FDA might not accept it because why should they review an application where the only difference is the labeling?).  Rather, you would just ​submit the labeling as part of annual report submission of labeling.


------------------------------
______________________________________________
Michael A. Swit, Esq.
Law Offices of Michael A. Swit
www.fdacounsel.com
San Diego, CA
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www.fdacounsel.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my law firm or any of our clients. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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------------------------------

Original Message:
Sent: 26-Jun-2018 13:54
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

From what I understand, you already have an approved NDA and wish to now market it (i.e. same NDA) as generic via ANDA? Yes, you can do it without prior approval but requires administrative notification. Big companies who had both branded and generic divisions do this all the time once the patent expires in addition to granting AG to another company!
Original Message:
Sent: 26-Jun-2018 10:51
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

I am not talking about Authorized Generic. I am talking about real ANDA. AG is still under PDUFA. This product is AG already, but we want to convert to real ANDA.
Original Message:
Sent: 25-Jun-2018 21:47
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

"ANDA applicant is the NDA owner, is it allowed?"

YES! The brand name big companies do this all the time! Please read and learn about authorized generic ANDA as a start.
Original Message:
Sent: 25-Jun-2018 11:42
From: Anonymous Member
Subject: ANDA refers to NDA

This message was posted by a user wishing to remain anonymous

Hi,
If I want to submit an ANDA which has identical CMC information (same API, formulation, manufacturing site, process, equipment, container closure...) to an approved NDA  and the ANDA applicant is the NDA owner, is it allowed? I could not find law/guidance says I cannot. I know 505b2 does not allow to do it. In addition, the ANDA product specific guidance requests PD study (not BE). Scientifically, I think the PD study could be waived since nothing change. But anyone has the suggestion or experience for such kind of submission?

Thank you