The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) from Elite Pharmaceuticals Inc (OTCBB: ELTP) for its methadone hydrochloride 5 mg and 10 mg tablets, the company revealed on Monday.

Glenmark Pharmaceuticals Inc (NSE: GLENMARK), Elite's marketing alliance partner, will sell and distribute the product, paying Elite manufacturing and licence fees.

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.

The drug can also be used for maintenance treatment of opioid addiction (heroin or other morphine-like drugs) in conjunction with appropriate social and medical services.

Annual retail sales for brand and generic methadone products are approximately USD30m, according to QuintilesIMS Health data.