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Romark Alinia "approvable" for adults, approval for children

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Romark Labs' Alinia (nitazoxanide) tablet formulation is deemed "approvable" for adult patients 12 years and older Nov. 22. FDA clears the oral suspension for pediatric patients ages one to 11 years on the same day. The new molecular entity is indicated for treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia. Alinia is also pending at FDA for use in AIDS patients. Romark says the product will be available in February 200

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