New Delhi: Dr Reddy’s Laboratories has received final approval from the US health regulator for generic version of Suboxone, prescribed for opioid addiction.
“The product approved by the US Food and Drug Administration (USFDA) is a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film,” Dr Reddy’s Laboratories said in a BSE filing.
The company, which is launching the product in the US, said approval has been granted in the strengths of 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg.
“Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment program including prescription monitoring, counseling, and psychosocial support,” Dr Reddy’s Laboratories said.
The Suboxone brand had US sales of approximately USD 1.86 billion for the twelve months ending in April 2018, DRL said citing IMS Health data.
Shares of DRL were trading at Rs 2,348.50 apiece in the morning trade, up 3.53 per cent, on the BSE.