COLUMBUS, Ohio — On Thursday Roxane Laboratories announced that its alosetron hydrochloride tablets — a generic version of irritable bowel syndrome treatment Lotronex — was available in 0.5- and 1-mg strength.
The U.S. Food and Drug Administration approved Roxane’s abbreviated new drug application for the medication on May 4, making an approximately $86 million annual market available to the company.
The news of the availability of Roxane’s IBS drug comes the same day that
the FDA approved two new brand-name IBS treatments, Patheon Pharmaceuticals’ Viberzi and Salix Pharmaceuticals’ Xifaxan.