The answer, like so many things, is that it depends. Many new dosage forms might be possible via an ANDA Suitability Petition if the person seeking to market the new dosage form is not the holder of the full NDA that would be designated by FDA as the reference listed drug (RLD) for generic versions of the branded product.
In addition, theoretically, a brand could file an ANDA petition for a dosage form change of its own product,but might want to avoid doing so as the ANDA petition process is public.
Thus, there are multiple ways to approach this adn it all depends on the planned dosage form change, how it differs from the originally approved drug, and who is seeking to implement the dosage form change.
______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
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maswit@duanemorris.com Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. 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: 11-23-2013 23:49
From: Tom Namsavanh
Subject: FDA New Dosage Form as Supplement
From my browsing of the Drugs@FDA site, I noticed all of the products (those of which I've come across) that have different dosage forms available for the same API have been submitted as NDA.
My question is if there is any regulations that prescribe such route. To me, I see the addition of a new dosage form as a prior approval supplement submission (of course, this does not apply to all cases). Let's look at the Claritin example:
US FDA
Claritin 10mg tablets: NDA 019658 (chemical type 1 new molecular entity)
Claritin Reditabs 10mg ODT: NDA 020704 (chemical type 3 new dosage form)
I would like to have your opinion on this.
Regards,
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Tom Namsavanh
Manager, Regulatory Affairs and Compliance
Intelgenx Corp.
Saint-Laurent QC
Canada
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