Romark's broad-spectrum antiparasitic Alinia (nitazoxanide) clears FDA June 16 for treatment of Cryptosporidium-induced diarrhea in adults and children ages 12 and above.

The supplement, which received a priority review, expands on the product's previous indication for younger children ages one to 11. The approval applies to both tablet and oral suspension formulations.

Cryptosporidium is found in 65%-97% of surface water in the U.S. and "is recognized as the leading cause of waterborne disease outbreaks," Romark said.

In addition to Cryptosporidium, Alinia carries an indication for treatment of diarrhea caused by Giardia lamblia in both adults and children.

The private company is understood to be seeking an indication for Crypto-induced diarrhea in AIDS patients. Labeling currently notes that efficacy has not been demonstrated in immunocompromised patients.

Romark also is looking at Alinia's use in Clostridium difficile-associated diarrhea and Crohn's disease.

- Lee Szilagyi

Romark Alinia Cryptosporidium Indication Expanded To Adults, Teens

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