Dr Reddy's Labs rises after USFDA final approval for generic

Dr Reddy's Laboratories rose 2.67% to Rs 2,329 at 9:31 IST on BSE after the company announced US drug regulator's final approval and launch of Buprenorphine and Naloxone sublingual film in the US market.

The announcement was made before market hours today, 15 June 2018.

Meanwhile, the S&P BSE Sensex was almost flat at 35,600.99.

On the BSE, 54,000 shares were traded in the counter so far compared with average daily volumes of 2.36 lakh shares in the past two weeks. The stock had hit a high of Rs 2345.95 and a low of Rs 2290 so far during the day. The stock hit a 52-week high of Rs 2,788 on 24 July 2017. The stock hit a 52-week low of Rs 1,888 on 21 May 2018.

Dr. Reddy's Laboratories announced that it has received final approval from the US Food and Drug Administration (USFDA) and is launching Buprenorphine and Naloxone sublingual film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the United States market. The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program.

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 program including prescription monitoring, counseling, and psychosocial support.

The Suboxone brand had US sales of approximately $1.86 billion MAT for the most recent twelve months ending in April 2018 according to IMS Health.

Dr Reddy's Laboratories' consolidated net profit fell 19.4% to Rs 272.10 crore on 0.54% fall in net sales to Rs 3534.90 crore in Q4 March 2018 over Q4 March 2017.

Dr Reddy's Laboratories is an integrated pharmaceutical company.

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