The Skinny On Skinny Labels

Law360, New York (September 8, 2011, 1:09 PM EDT) -- The law surrounding U.S. Food and Drug Administration section viii certifications is currently in flux due to recent decisions of the Federal Circuit, Novo Nordisk v. Caraco Pharm. Labs. Ltd. and AstraZeneca LP v. Apotex Inc. The importance of this area of law is highlighted by the amicus curiae briefs filed by the solicitor general and five major generic industry groups requesting that the U.S. Supreme Court grant certiorari in Novo Nordisk.

A section viii statement is a certification submitted in connection with an Abbreviated New...
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