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Home » Judge Approves FDA’s Plan B Proposal, Argues Against Teva Exclusivity
Judge Approves FDA’s Plan B Proposal, Argues Against Teva Exclusivity
June 14, 2013
U.S. District Judge Edward Korman has agreed the government’s proposal to approve a new sNDA for Teva’s Plan B One-Step without age or point-of-sale restrictions satisfies his April 5 order. However, he argued against the FDA granting Teva any period of market exclusivity that would delay access to generic versions.