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...