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(Message started by: patty on Nov 6th, 2007, 12:52am)

Title: Section 507 of the Federal Food, Drug and Cosmetic
Post by patty on Nov 6th, 2007, 12:52am
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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