BRIDGEWATER, N.J., Jan. 30, 2017 /PRNewswire/ -- 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 http://www.amneal.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.
Amneal Pharmaceuticals LLC, a privately-held company headquartered in Bridgewater, New Jersey, is one of the largest and fastest growing generics pharmaceutical manufacturers in the United States. Founded in 2002, Amneal now has more than 4,000 employees in its operations in North America, Asia, Australia and Europe, working together to bring high-quality affordable medicines to patients worldwide. Amneal has significantly expanded its portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas. For more information, visit www.amneal.com.
All trademarks listed in this release are property of their respective owners.
Jim Luce (sales)
Executive Vice President, Sales & Marketing
Cheryl Lechok (media)
President, Cheryl Lechok Communications
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/amneal-introduces-alosetron-hydrochloride-tablets-new-generic-for-lotronex-300398622.html
SOURCE Amneal Pharmaceuticals LLC