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