rajasekharkakarla
Junior

India,
2018-07-24 09:05

Posting: # 19087
Views: 914
 

 Reference trademark issue [Regulatives / Guidelines]

Dear All,

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.

Regards'
Kakarla
Helmut
Hero
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Homepage
Vienna, Austria,
2018-07-24 16:57

@ rajasekharkakarla
Posting: # 19093
Views: 977
 

 Note to File

Hi Kakarla,

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.

Cheers,
Helmut Schütz
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rajasekharkakarla
Junior

India,
2018-07-30 13:37

@ Helmut
Posting: # 19115
Views: 1,107
 

 Note to File

Dear Sir,

Thank you for your clarification.

Thanks and Regards,
Kakarla Rajasekhar
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