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

Romark Alinia Adult Dose “Approvable”; Anti-Parasitic Approved For Children

Executive Summary

Romark Labs' Alinia for treatment of intestinal parasites in adults could be approved by FDA as early as mid-2003 following receipt of an "approvable" letter Nov. 22, the company said

You may also be interested in...



Romark Alinia approved

FDA approves Romark Labs' Alinia (nitazoxanide) Nov. 22 for treatment of diarrhea in pediatric patients caused by Cryptosporidium parvum and Giardia lamblia. NTZ was originally licensed by Tampa-based Romark to Unimed for development as a treatment of cryptosporidial diarrhea associated with AIDS under the name Cryptaz. The privately held company re-acquired rights to the drug in 1998 after Unimed decided not to conduct additional studies suggested by FDA's Antiviral Drugs Advisory Committee (1"The Pink Sheet" May 18, 1998, In Brief). Alinia (NDA 21-498) is approved as a "1-P" new molecular entity given a priority review...

Unimed Cryptaz

Company will not pursue cryptosporidial diarrhea indication for nitazoxanide and will not perform the necessary additional studies recommended by FDA's Antiviral Drugs Advisory Committee May 6, firm says ("The Pink Sheet" May 11, p. 6). Unimed maintained that the decreasing rate of CD in AIDS patients due to new antiretroviral therapies and the fact that many patients are obtaining nitazoxanide from Mexico makes it difficult to enroll people in trials. No new patients will be enrolled in the "compassionate use" protocol but patients currently enrolled will continue to receive the drug free of charge

Unimed Cryptaz Dose Comparison Study To Show Efficacy Suggested By Cmte.

Efficacy for Unimed's Cryptaz could be demonstrated through a small dose comparison study, members of FDA's Antiviral Drugs Advisory Committee suggested at its May 6 meeting.

UsernamePublicRestriction

Register

OM013164

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