PharmPK Discussion - Amiodarone tablets

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On 23 Nov 2004 at 14:35:21, "R Singaravelan" (rsingaravelan.at.glenmarkpharma.com) sent the message

Dear all,
Can someone help me out.
We wanted to do bioequivalence for Amidarone for all strengths
100,200,300 and 400mg tablets.
As per the latest information on Orange book, none of the existing
product of Aminodarone HCl Tablets is listed as a Reference listed drug
(RLD). The only RLD we find is the Amiodarone HCl Injection 50mg/mL by
Wyeth pharms.
There are about 7 generic companies having 200mg and  they all have done
their Bio studies using Cordarone.at.200mg, a Wyeth Pharma product as their
RLD. Eon has 400m g strength and Taro has 300 mg strength. Some time
back, Taro was having 400mg (they did bio for 400 with Eons 400 and got
waiver for 300mg) which was given RLD status but now Taro 400 mg is
withdrawn.
We want to do one bio study to cover all the strengths.
Which one is to be considered as RLD.
Regards,
R.S.Velan
Regulatory affairs

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