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FDA approves Suboxone generic variant to treat opioid dependence – Pharmaceutical Technology

by JMC on June 18, 2018

The US Food and Drug Administration (FDA) has granted Mylan Technologies and Dr. Reddy’s Laboratories marketing approval for generic versions of Suboxone (buprenorphine and naloxone) sublingual film to treat opioid dependence.

The approval enables the launch of various strengths of the drug in the US market, including 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg variants.

Buprenorphine suppresses withdrawal symptoms from the discontinuation of opioid drugs, while naloxone reverses and blocks the effect of opioids.

The combination of these medications can now be used as part of a complete treatment programme that includes prescription monitoring, counselling and psychosocial support.

Only people certified under the Drug Addiction Treatment Act (DATA) can prescribe buprenorphine and naloxone.

The common adverse side effects of Suboxone sublingual film are numbness, oral mucosal erythema, headache, nausea, vomiting, excessive sweating and constipation.

“The FDA is facilitating market entry of generic versions of approved drugs for opoid use disorder to help ensure broader access.”

FDA commissioner Scott Gottlieb said: “Patients addicted to opioids who are eventually treated for that addiction, and successfully transition onto medicines like buprenorphine, aren’t swapping one addiction for another, as is sometimes unfortunately said.They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids.”

The approval comes as the regulatory authority is working towards advancing improved treatments for opioid use disorder and making them available for patients.

The FDA’s efforts involve promotion of development of better drugs and allowing market entry of generic versions of already approved medications.

Gottlieb said: “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.”

Source: FDA approves Suboxone generic variant to treat opioid dependence – Pharmaceutical Technology

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