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Plan B OTC Submission Deemed "Not Approvable"

This article was originally published in The Pink Sheet Daily

Executive Summary

Barr will have to detail a mechanism for drugstores to screen women less than 16 years of age for nonprescription use of the emergency contraceptive. FDA's decision goes against the recommendation of its advisory panels.

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Barr Submits Plan B Response To FDA, Starts 180-Day Review Clock

Response to "not approvable" letter for OTC availability of the emergency contraceptive includes information supporting Rx-only status for women 15 years of age and under and OTC status for women 16 and older.

Barr Submits Plan B Response To FDA, Starts 180-Day Review Clock

Response to "not approvable" letter for OTC availability of the emergency contraceptive includes information supporting Rx-only status for women 15 years of age and under and OTC status for women 16 and older.

Bad Precedent? Plan B Rx/OTC Labeling May Have Implications For Existing OTCs ­– NEJM

Nonprescription drugs, such as aspirin and ibuprofen, could be reevaluated if Barr chooses simultaneous Rx/OTC marketing of levonorgestrel at the same dose for both populations.

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