Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Canadian Plan B Pharmacy Status Proposal Will Not Address Age Restriction

This article was originally published in The Tan Sheet

Executive Summary

Discussion of an age restriction for purchase of Barr Labs' Plan B (levonorgestrel) will not be included in the Canadian government's evaluation of a potential switch to behind-the-counter status for the emergency contraceptive

You may also be interested in...



CDER’s Galson Cites Application Flaws, Not Politics, In Plan B Decision

Barr Labs submitted a marketing plan for behind-the-counter sale of Plan B (levonorgestrel .75 mg), but FDA was "unable" to review the package

ECs in Canada

Women's Capital Corp.'s progestin-only morning-after pill, Plan B, could be available "behind-the-counter" in Canada within a year, group says. WCC submitted an application to Health Canada March 6 to switch the EC from prescription-only to nonprescription status; if approved, Plan B would be dispensed by trained pharmacists operating under a protocol developed by the Canadian Pharmacists Association and Society of Obstetricians & Gynecologists of Canada. Application includes results from a label comprehension study of 600 American women, as well as post-marketing safety data from Europe. WCC also is in final stages of an actual-use study involving 600 women in Washington; once it is complete, the group will have enough information to submit an application to FDA, which it plans for late summer...

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

Topics

UsernamePublicRestriction

Register

PS096843

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel