Pink Sheet is part of the Informa Intelligence Division 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

“Paper NDAs”

This article was originally published in The Tan Sheet

Executive Summary

Pursuing Rx-to-OTC switches under section 505(b)(2) of Hatch/Waxman patent law is "potentially a very good avenue" for companies to use, Morgan Lewis lawyer Stephen Paul Mahinka says at Regulatory Affairs Professionals Society annual conference in Washington, D.C. Oct. 9. Both Wyeth and McNeil used 505(b)(2) application, or "paper NDA," approach to seek OTC approval for loratadine (Schering-Plough's Claritin) (1"The Tan Sheet" Feb. 4, 2002, p. 3). Mahinka expects "some response" from FDA in next several months on citizen petition filed by Pfizer and Pharmacia in 2001 requesting FDA disallow 505(b)(2) NDAs from relying on innovator's data...
Advertisement

Related Content

Claritin Patent Infringement Suit Brings Industry Into OTC Antihistamine Fray
Claritin Patent Infringement Suit Brings Industry Into OTC Antihistamine Fray

Topics

Advertisement
UsernamePublicRestriction

Register

PS094651

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

Cancel