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

Fison’s Proferdex

Executive Summary

FDA approval of Fison's NDA for the iron dextran injectable product is "reinstated," a Nov. 23 Federal Register notice says. Fisons had requested the withdrawal of the NDA (17-807) in July 1991. In an April 15 letter, however, the firm told FDA that the Proferdex NDA and product "constitute viable and valuable corporate assets, and Fisons intends to explore the supply, either directly or indirectly, of Proferdex product to the market." Fisons attested that the company was in "good faith negotiations" with Lotus Biochemical Corp. of Bland, Va., and other firms to "provide rights" to Proferdex to third parties. Fisons' iron dextran injection sold under the tradename Imferon, for which the company holds a separate NDA, has been unavailable in the U.S. since May 1991 due to manufacturing compliance problems at the firm's U.K. facility.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS021833

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