Dr. Reddy's Laboratories Limited (NYSE: RDY) rose Friday after the company reported the FDA final approval and launch of Buprenorphine and Naloxone Sublingual Film in the U.S. market.
The company, headquartered in India and in Princeton, New Jersey, announced Thursday that 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," explains the news release, "is used as part of a complete treatment program including prescription monitoring, counseling, and psychosocial support"
In a statement released earlier today by the USFDA, Commissioner Scott Gottlieb, explained, "The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them.
"That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access."
Said Reddy CEO Alok Sonig, "This approval is an important milestone for our company and a testament to our commitment to bring affordable generic medicines to market for patients. Our company will continue to look for opportunities to acquire and manufacture assets that accelerate access to innovative and affordable medicines for patients."
The Suboxone® brand had U.S. sales of approximately $1.86 billion MAT for the most recent 12 months ending in April according to IMS Health.
Shares leaped $2.05, or 6.2%, to 35.07
