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In a letter to the Center for Reproductive Rights denying the petition, the FDA disclosed for the first time that Teva would have had three years of exclusivity for full non-prescription sales of Plan B One-Step if the application had been approved.
WSJ: FDA Keeps Limits on Other 'Plan B' Contraceptive
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"The FDA's approval of Teva's current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge's ruling, " the FDA said in a statement.
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Teva had submitted two studies to the FDA earlier this year seeking approval of its application to fully lift prescription requirements for Plan B One-Step.
WSJ: FDA Keeps Limits on Other 'Plan B' Contraceptive