Qualitest Receives FDA Approval for Levetiracetam Extended-Release Tablets, 500mg and 750mg
HUNTSVILLE, Ala., July 25, 2012 /PRNewswire-FirstCall/ — Qualitest Pharmaceuticals today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg, the generic equivalent of UCB’s Keppra XR®.
The total combined sales for Levetiracetam extended-release tablets, 500mg and 750mg, in the U.S. for the 12 months ending May 31, 2012, were approximately $124.8 million according to IMS Health.
Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is an operating company of Endo Health Solutions Inc. (NASDAQ: ENDP) a US-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates maximum value for patients, providers and payers alike. Learn more at www.endo.com.
SOURCE Endo Health Solutions Inc.