Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Plan B: What Came Before, Where It Can Go And What It All Means

This article was originally published in The Tan Sheet

Executive Summary

Barr Labs appears to have no legal recourse following FDA's failure to meet the PDUFA deadline for the firm's Plan B emergency contraceptive switch if the agency chooses to delay a decision on the application indefinitely

You may also be interested in...



NDAC Approach To OTC Switches Highlighted At Corticosteroid Meeting

Panel review provides examples of different attitudes toward switches between OTC experts, other category-specific prescribers.

Plan B Decision Expected In Coming Weeks, Barr CEO Says

Downey says Rx sales of approximately $20 mil. have restricted availability of the emergency contraceptive at pharmacies across the country.

Topical Corticosteroid Adrenal Suppression Risk Precludes OTC Use, Advisory Committe Says

Topical corticosteroid HPA axis suppression risk under "maximal use conditions" should preclude the OTC marketing of the dermatologic products, FDA advisory committees say. Test for hypothalamus, pituitary, adrenal axis suppression is only 70% accurate, committee members note.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS097671

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