HBW Insight 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


FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs

This article was originally published in The Tan Sheet

Executive Summary

FDA believes additional information on whether a drug can be marketed both Rx and OTC for the same indication is needed before a decision can be reached on Barr Labs' switch application for Plan B

You may also be interested in...

Barr, FDA Will Meet On Plan B Switch; Agency Says Rulemaking Not Needed

The approval process for the over-the-counter sale of Barr's emergency contraceptive Plan B could be "wrapped up in a matter of weeks if [Barr and FDA] work diligently" together, according to an FDA spokesperson

FDA Depositions Reveal Crawford’s Prominent Role In Plan B Switch Review

The role of high-level FDA officials in the review of Barr Labs' Rx-to-OTC switch application for Plan B was required by the "high-profile" nature of the NDA, according to Center for Drug Evaluation & Research Director Steven Galson

FDA Topsiders Must Testify In Plan B Case – Judge

The Center for Reproductive Rights will be allowed to take depositions from certain FDA "senior decision-makers" in their suit against the agency over decisions related to emergency contraceptive Plan B

Related Content





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