Bridgewater, NJ (USA), January 30, 2017 – Amneal Pharmaceuticals LLC has launched alosetron hydrochloride tablets, an AB-rated generic equivalent to Lotronex®, in 0.5 mg and 1 mg strengths. Manufactured in Brookhaven, NY, the product began shipping in 30-count bottles on January 27 through wholesalers, distributors and directly to the trade.
Alosetron hydrochloride is the second new product to ship from Amneal in the 2017 calendar year following aspirin and extended-release dipyridamole capsules. Alosetron is Amneal’s 105th molecule to be approved through the ANDA process and represents the company’s first product in this therapeutic class. The Amneal product is one of only two FDA-approved generic-equivalents for Lotronex® currently available.
Amneal’s generic received FDA approval under a Risk Evaluation and Mitigation Strategy (REMS) known as the Alosetron REMS Program. Information on this REMS Program is available at https://www.alosetronrems.com or 1-844-267-8675.
Visit https://india.amneal.com/dev.php7-30.phx1-1.websitetestlink.com/wp-content/uploads/2017/01/AlosetronHydrochloride-pi.pdf to view full prescribing information for alosetron hydrochloride tablets.
Annual U.S. sales of Lotronex® were $50 million according to November 2016 IMS market data.