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Glenmark's partner Elite gets USFDA nod for opioid analgesic drug

Press Trust of India  |  New Delhi 

Glenmark Pharmaceuticals today said its partner has received approval from the US health regulator for generic opioid hydrochloride tablets used for treatment of severe

The abbreviated new drug application (ANDA) approval by the 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 for which Elite will receive and licence fees, it added.

"Based on Health data, the for the brand and were approximately USD 30 million," Glenmark said.

The product is indicated for the management of severe enough to require daily, round-the-clock, long-term opioid treatment and for which are inadequate, it added.

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.

Shares of Glenmark were today trading at Rs 592.15 per scrip on BSE, down 1.09 per cent from its previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, August 07 2018. 14:01 IST
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