Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCBB: ELTP), a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it received approval from the U.S. Food and Drug Administration (FDA) for the Company’s abbreviated new drug application (ANDA) for methadone hydrochloride 5 mg and 10 mg tablets. Methadone is indicated for the management of pain severe enough to require daily, around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate. Methadone can also be used for maintenance treatment of opioid addiction (heroin or other morphine-like drugs) in conjunction with appropriate social and medical services.
Glenmark Pharmaceuticals, Inc., Elite’s marketing alliance partner, will sell and distribute methadone for Elite for which Elite will receive manufacturing and license fees. Based on QuintilesIMS Health data, the annual retail sales for the brand and generic products were approximately $30 million.
“I am pleased to receive FDA approval for our methadone ANDA filing. We expect methadone to be a key product for our marketing alliance with Glenmark Pharmaceuticals,” stated Nasrat Hakim, President and CEO of Elite. “This is our second product approval in the last 30 days. We have four additional ANDAs and an NDA for SequestOx™ currently filed with the FDA.”
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