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Home » FDA Delays Plan B Decision; Wants Regulatory Clarity on Dual Rx-OTC Drug Status
FDA Delays Plan B Decision; Wants Regulatory Clarity on Dual Rx-OTC Drug Status
September 2, 2005
The FDA has asked the public to weigh in on how it determines when a drug may be marketed as both a prescription and an OTC product -- a move that was prompted by the FDA's inability Aug. 26 to rule on Barr Pharmaceuticals' OTC application for the Plan B emergency contraceptive.