Elan Naprelan FTC subpoena
Executive Summary
Elan is responding to a December 2002 Federal Trade Commission subpoena regarding Naprelan, company discloses in Feb. 27 Securities & Exchange Commission filing. FTC opened an investigation in June 2001 to determine whether Elan had restricted generic availability of Naprelan (naproxen). Andrx brought suit against Elan and SkyePharma, claiming they had entered into an anti-competitive agreement for the pain agent (1"The Pink Sheet" April 9, 2001, p. 4). SkyePharma later waived its right to 180-day exclusivity, clearing the way for Andrx' generic (2"The Pink Sheet" July 15, 2002, p. 7)...
You may also be interested in...
Naprelan Generic Exclusivity Settled; Andrx Sees Three Near-Term Launches
SkyePharma has waived its 180-day exclusivity for a generic version of Elan's Naprelan (naproxen), clearing the way for approval of Andrx' generic version of the product, Andrx says
Andrx/Aventis Settle With FTC: Agency Says Cardizem CD Generic Not Delayed
Aventis and Andrx' consent agreement with the Federal Trade Commission includes an acknowledgement by the agency that the patent litigation settlement between the two companies did not delay the advent of generic competition to Cardizem CD.
EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions
The European Medicines Agency is training scientific staff working for the European medicines regulatory network in how to use a new AI-powered search engine that allows them to easily retrieve information on regulatory precedents.