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Amneal ships Lotronex generic

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BRIDGEWATER, N.J. — Amneal Pharmaceuticals LLC has released alosetron hydrochloride tablets, a treatment for irritable bowel syndrome (IBS) in women.

Amneal Lotronex genericAmneal said its alosetron hydrochloride product, a generic version of Lotronex from Sebela Pharmaceuticals Inc., comes in 0.5-mg and 1-mg strengths and began shipping in 30-count bottles through wholesalers, distributors and directly to the trade this month.

Alosetron hydrochloride tablets mark Amneal’s first medication in this therapeutic class, the company said, adding that its product is one of only two Food and Drug Administration-approved Lotronex generics currently available.

Indicated for use after other IBS treatments have proved unsuccessful, alosetron hydrochloride tablets treat severe, chronic IBS symptoms in women who have had diarrhea as the primary symptom for at least six months.

U.S. sales of Lotronex totaled $50 million for the 12 months ended in November 2016, according to IMS Health market data reported by Amneal.

Amneal added that alosetron hydrochloride tablets are its second new product to ship in the 2017, following aspirin and extended-release dipyridamole capsules.


ECRM_06-01-22


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