Romark Alinia Tab. Approval Expected First Half 2004; AIDS Claim To Follow
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Romark expects approval in the first half of 2004 for a tablet formulation of its antimicrobial Alinia for use in immunocompetent adults and adolescents with diarrhea associated with Giardia lamblia and Cryptosporidium parvum.
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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