New Delhi: Glenmark Pharmaceuticals said its partner Elite Pharmaceuticals Inc has received approval from the US health regulator for generic opioid analgesic methadone hydrochloride tablets used for the treatment of severe pain.
The abbreviated new drug application (ANDA) approval by the United States Food and Drug Administration (USFDA) is for the tablets in the strengths of 5 mg and 10 mg, Glenmark said in a statement.
Glenmark Pharmaceuticals Inc, Elite’s marketing alliance partner, will sell and distribute methadone for which Elite will receive manufacturing and license fees, it added.
“Based on Quintiles IMS Health data, the annual retail sales for the brand and generic products were approximately USD 30 million,” Glenmark said.
The product is indicated for the management of pain severe enough to require daily, round-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, it added.
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 said.