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I am working on development of Local anesthetic and/or aseptic using
oral sprays for mouth diseases. I want to know if Innovator exists in
EU market; by comparing and evaluation pharma equivalence - Can it
still possible to get approval without unnecessary bio equivalence
study?
Another aspect want to clarify, if you kept same active ingredient
drug concentration as innovator in oral spray but changing excipients
accordingly; still exists possibility to get generic approval for the
same.
With Regards,
Devang Purohit
Research Scientist, Pharma Research
Ranbaxy Labs Ltd
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Devang
Where are you targeting to market the product EU or elsewhere?
if the EU is the target go to
http://www.emea.europa.eu/htms/human/epar/eparintro.htm
to look for the product. If it is not listed here it may be in the
approval process or not filed yet.
If the target is US then go to
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
If it is not there the implication is the same that it may be under
review.
I am not sure if you could really get away with NOT doing a BE study
esp in the US. First is it really a topical product (min or no
systemic absorption) or a topical product for systemic delivery? If
you can measure the systemic levels accurately then i would personally
conduct an in vivo PK BE study. In addition, If the spray is NOT a
solution then you may have to do a BE study for certain. For oral
sprays you need to be Q1/Q2 to be a Generic in the US.
I am not sure of the EU regulatory laws.
Hope this helps
Manish Issar, Ph.D
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In the US, oral sprays for local action are regulated as nasal sprays.
There is a specific FDA guidance for in vitro BE testing
http://www.fda.gov/cder/guidance/5383DFT.pdf
There is also some specific statistics for this
http://www.fda.gov/cder/guidance/5383stats.pdf
Frank
Frank Bales, Ph.D.
Email: frankbales.at.msn.com
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