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


Watson aims for August launch of EC

This article was originally published in The Tan Sheet

Executive Summary

The maker of the just-approved Next Choice emergency contraceptive, a generic of Teva's Plan B (levonorgestrel), applies to make the drug available for nonprescription sale upon the expiration of Teva's market exclusivity Aug. 24. A spokeswoman said June 29 that Watson Pharmaceuticals is confident FDA will approve the Next Choice nonprescription application, but does not know whether the decision will come before Plan B loses exclusivity. FDA likely will apply to non-Rx levonorgestrel generics the same age restriction on pharmacy-only sales it imposed on Plan B (1"The Tan Sheet" June 29, 2009). Watson reserves the right to later seek universal OTC sales status, the spokeswoman said

You may also be interested in...

Generic Rx Plan B Approval Points To Possible OTC Equivalents In Near Future

FDA's approval of a generic prescription-only Plan B makes a nonprescription generic of the emergency contraceptive likely, potentially as early as August

Indo-German Collaboration Delivers Novel Diabetic Foot Ulcer Treatment

Centaur-CytoTools introduces novel topical treatment for diabetic foot ulcers in India, for which they see limited direct competition and hope to change the way the difficult-to-treat diabetes complication is managed. Phase III studies are ongoing in Europe.

QUOTED. 1 October 2020. Stephen Hahn.

The head of the US Food and Drug Administration praised the life-saving work of device center staff in response to the coronavirus pandemic.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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