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Re: DewDiligence post# 102031

Friday, 08/20/2010 12:20:00 PM

Friday, August 20, 2010 12:20:00 PM

Post# of 257253
You sure about that?

Here's the official policy statement from one state:

A drug will be considered eligible for P&T Committee review if it meets one of the following criteria:
• A “new brand” drug defined by the FDA as having the new drug application (NDA) approved which indicates that the product may be marketed in the United States
• A “new brand of an established generic” and has met the FDA definition above of “new brand”
• A “First Generic” on the monthly FDA update of “Generic Drug Approvals”. First Generics are those drug products that have not previously been approved as generic drug products and are new to the marketplace.
Drugs that meet these criteria are included on the agenda of the next P&T Committee meeting for review, regardless of whether an annual review is conducted for the respective drug class

Because M-enoxaparin is a first generic, the drug will be reviewed more quickly than Reco, but it will still require review.

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