Glenmark Pharmaceuticals’ partner Elite Pharmaceuticals receives US FDA approval for generic methadone hydrochloride tablets

Glenmark Pharmaceuticals Ltd, a research-based global integrated pharmaceutical company, announced today that its partner Elite Pharmaceuticals, Inc., a US specialty pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for the 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.


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