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   Section 507 of the Federal Food, Drug and Cosmetic
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   Author  Topic: Section 507 of the Federal Food, Drug and Cosmetic  (Read 1330 times)
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Section 507 of the Federal Food, Drug and Cosmetic
« on: Nov 6th, 2007, 12:52am »
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Section 507 of the Federal Food, Drug and Cosmetic Act (antibiotic products). Drug products of this category will not have patents listed.
 
Drug product X does not have patent listed in the Electronic Orange book as per sec. 507. However the sale pack of product X indicates two US patent nos. The two patent nos have paediatric exclusivity. These two patent are listed in OB for combination product (another product). Product approved under sec 507 - antibiotic products were not eligible for exclusivity protection.
 
Query:
What is the effect of paediatric exclusivity on the product X ?
What is the consequence of displaying patent nos on the sale pack?
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