What would be the regulatory path for an Authorized generic, in general?
Authorized Generics (AG) are prescription drugs that are produced by the NDA holder and marketed under a private label, at generic prices. This circumstance typically presents itself when the NDA holder still has patent protection for the product on the market. Authorization of a [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, December 21st, 2009.
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