DC District Court Sides With FDA In Alphapharma's Celexa Patent Challenge

Law360, New York (August 17, 2004, 12:00 AM EDT) -- A U.S. District Judge has dismissed a patent challenge to Forest Laboratories' antidepressant drug Celexa by Australian drugmaker Alphapharm Pty. Ltd., upholding a decision by the U.S. Food and Drug Administration to deny Alphapharm’s Abbreviated New Drug Application (ANDA) to market a generic version of the drug.

In his ruling, U.S. District Judge James Robertson of the U.S. District Court for the District of Columbia said the FDA had "properly refused" to accept Alphapharm's ANDA.

Robertson said in his opinion the FDA's role in reviewing patent...
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