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Health Canada required Apotex to submit additional safety, effectiveness, and quality data for its ANDS, citing the different salt form as the basis for its decision
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helping Judi with a mailing list for the International Children’s Right’s Campaign, which
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clinical trials had suffered a “serious adverse event.” See: Robert Temple Risperdal approval
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There is a great deal of confusion out there: Thanks for adding this information to the ongoing, and hopefully rational, discussion.
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