The advice is correct. You cannot get a "new" indication for a drug via the 505j (ANDA) approval pathway. A new indication -- even for an "old" drug -- makes the application "new." Thus, you'd have to file an NDA. In general, filing an NDA, whether via 505(b)(1) or 505(b)(2), will mean some significant investment into clinical study, the 505(b)(2) pathway simply allowing you to reference the drug product that is already on the market for information that may be supportive such that you would not have to repeat the work (e.g. pre-clinical safety). There is an FDA guidance document regarding the 505(b)(2) pathway you may want to review. While your approval may in fact give only you the legal right to then market your drug for this new indication (regardless of the branded name you decide to use), there is nothing to stop physicians from prescribing the drug by chemical name only such that patients could be given the generic at a much lower price. All this to say you really need to do your homework on the return on investment.
Chris
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Christopher Smith, CQE, RAC
Coastal Pharmaceutical Consultants, Inc.
7950 Old River Road
Burgaw, NC 28425, USA
910.259.8877 (land)
910.789.1232 (mobile)
chrissmith@coastalpharmaconsultants.com -------------------------------------------
Original Message:
Sent: 04-11-2015 07:43
From: John Lay
Subject: Repurposing generic drugs
The required pathway for a change or addition to indications is a 505(b)(2).
The problem with adding indications to a generic drug you will have to have a named generic in order to get the docs to write the prescriptions with your products name. Otherwise if he writes the generic name and it can go to any company with the approved generic. If it were my money I would file a 505(b)(1) with a new CMC section, with a branded name and the new clinical indication.
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John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States
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Original Message:
Sent: 04-10-2015 16:34
From: Hoi Cheong
Subject: Repurposing generic drugs
Dear regulatory professionals,
I hope this finds you well. Could you advise me on the differences in the pathways that are required to approve generic drugs for new indications (between rare and common diseases (>200,000 people))? Do you see financial incentives in doing so despite off-label use?
I am working on a NSF project initiative and hope to get some guidance.
Thank you for your advice.
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Hoi I (Queenie) Cheong
PhD Candidate
Cleveland OH
United States
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