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FDA Approves Generic Versions of Suboxone

FDA Web site; 2018 Jun 14

The US Food and Drug Administration (FDA) recently approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. This product may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers. Mylan Technologies Inc., headquartered in St. Albans, VT, and Dr. Reddy's Laboratories SA, headquartered in Hyderabad, India, received approval to market buprenorphine and naloxone sublingual film in multiple strengths.

Dosage/administration: Suboxone sublingual film is administered as a single daily dose.

  • Sublingual administration: Place 1 film under the tongue, close to the base on the left or right side, and allow to completely dissolve.
  • Buccal administration: Place 1 film on the inside of the left or right cheek and allow to
  • completely dissolve.
  • Suboxone sublingual film must be administered whole. Do not cut, chew, or swallow it.

Adverse effects: Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema (accumulation of fluid causing swelling in lower limbs).


FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence. FDA Web site. June 14, 2018. Accessed June 18, 2018.