(1897 d 07:40 ago)
Posting: # 19087
I prepared protocol for Mesalamine delayed-release tablets 1.2 gm for USFDA submission, i written reference name as Lialda™ (mesalamine) delayed release tablets 1.2 gm with trademark TM and the protocol was approved by EC. But as per COA it is mentioned as Lialda®, there is change in trademark. kindly suggest whether i need to go with ammendment/not.
(1896 d 23:48 ago)
Posting: # 19093
IMHO, no big deal.
™ stands for an unregistered trademark, as opposed to an registered trademark ®. Will not affect the safety of the subjects in the study. Hence, no substantial amendment (EC and regulatory approval) is required. Maybe just a “Note to File” is enough. If you want to be on the safe side, go for an administrative amendment.
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(1891 d 03:07 ago)
Posting: # 19115
Thank you for your clarification.
Thanks and Regards,