FDA approves Amneal Pharmaceuticals' Tramadol/APAP tablets

Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength (Tramadol/APAP) in tablet form effective December 9, 2009. Amneal’s generic is an AB-rated, therapeutically equivalent alternative to Ultracet® (a licensed trademark of Ortho-McNeil Janssen). U.S. sales of Tramadol/APAP were $61 MM according to June 2009 IMS Health market data.

“Tramadol/APAP is a logical extension of our well-established Tramadol line, which enjoys a solid market share in the industry”

Tramadol/APAP is a centrally-acting analgesic indicated for the short-term management of moderately severe acute pain. The product is designated a controlled substance in some states.

Amneal began shipping Tramadol/APAP in 100-, 500- and 1000-count sizes on January 25, 2010. It will be available through wholesalers-distributors as well as directly to the trade. The oral solid is manufactured in the company’s cGMP-compliant Hauppauge, NY production facility. Amneal manufactures all of its own products in the USA.

“Tramadol/APAP is a logical extension of our well-established Tramadol line, which enjoys a solid market share in the industry,” said Jim Luce, Amneal Executive Vice President, Sales & Marketing. He continued, “Our total commitment to rapidly expanding our product portfolio, manufacturing the highest quality products and delivering outstanding customer service combined to power Amneal’s prescription growth of 114% from 2008 to 2009, the highest in the generics industry according to IMS Health.”

Tramadol/APAP joins Amneal’s diversified portfolio of 250 products, listed in the company’s on-line product catalog at www.amneal.com. Launched last year, the comprehensive web catalog is designed for easy customer and patient access to essential information, images and literature such as product outserts, labels, patient medication guides, MSDS (material safety data sheets) and high-resolution product photos.