19 June 2018 - - Silver Spring, Maryland-based public health protection provider US Food and Drug Administration has approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence, the agency said.
Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD). Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse.
One of the ways the FDA is encouraging access and wider use of MAT is through the approval of generic versions of these products. In an effort to promote competition to help reduce drug prices and improve access to safe and effective generic medicines for Americans, the agency is taking a number of new steps as part of its Drug Competition Action Plan, including improving the efficiency of the generic drug approval process and addressing barriers to generic drug development.
Generic drugs approved by the FDA have, among other things, the same quality as brand-name drugs. Generic drug manufacturing and packaging sites must meet the same quality standards as those of brand-name drugs.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.