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Manufacturing CBE 30s took six months for FDA to review

This article was originally published in The Gold Sheet

Executive Summary

After six months, FDA Jan. 29 approved a "Changes Being Effected in 30 days" supplement that the agency had received July 29, 2008, from Valeant Pharmaceuticals International, Aliso Viejo, Calif., for an alternate repackaging site for its Mysoline (primidone) 50 mg tablets…. The agency took six months to review another CBE 30, this one from Bracco Diagnostics, Princeton, N.J. The approval came Nov. 26, 2008, for an application FDA had received May 27, 2008, for an alternate manufacturing site for its Technetium Tc 99m Medronate preparation kit

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