The US court barred DRL from sales and commercialisation of Buprenorphine and Naloxone Sublingual Film
Dr Reddy’s Laboratories (DRL) announced its intent to appeal the decision made by the US District Court for the District of New Jersey in a preliminary injunction hearing with respect to further sales and commercialisation of DRL’s Buprenorphine and Naloxone Sublingual Film within the US.
The company disagrees with the court’s decision, and will vigorously appeal it.
DRL had announced the receipt of the approval, on June 15, 2018 by one of its wholly-owned subsidiaries, from the US Food and Drug Administration (US FDA) for its Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the US market.