Generics
Dr Reddy's Laboratories reports availability of Buprenorphine and Naloxone Sublingual Film in the US Market
18 June 2018 -

Pharmaceutical company Dr Reddy's Laboratories Ltd (BSE:500124) (NSE:DRREDDY) (NYSE:RDY) reported on Friday the final approval from the US Food and Drug Administration (USFDA) for the Buprenorphine and Naloxone Sublingual Film in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg for treating opioid dependence/addiction.

Following the US FDA approval, the Buprenorphine and Naloxone Sublingual Film in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg will now be marketed in the US.

Additionally, the Buprenorphine and Naloxone Sublingual Film in 8 mg/2 mg is being launched under approved Risk Evaluation and Mitigation Strategy (REMS) Programme, stated the company.

Buprenorphine and Naloxone Sublingual Film in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg is the therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film.

According to the company, buprenorphine and naloxone are used to treat adults with opioid dependence/addiction. 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 programme including prescription monitoring, counseling and psychosocial support.

For the most recent 12 months ending in April 2018, the company's Suboxone brand had US sales of about USD1.86bn MAT, according to IMS Health.

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