PROZAC CASE
July 1st, 2004
BY KEITH NUTHALLGENERIC manufacturers can rely on existing data for medicines they are copying to expedite marketing approvals, even if in a different form, a European Court of Justice (ECJ) advocate general has recommended. Francis Jacobs advised judges to allow Britain's Approved Prescription Services Ltd to use Prozac capsule data under medicinal products directive 2001/83/EC, even though its generic fluoxetine liquid mimicked Prozac liquid, whose market authorisation had been secured for less than the 10 years required for its data to be used in generic ...
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