FDA clears Dr. Reddy’s generic Suboxone sublingual film

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FDA clears Dr. Reddy’s generic Suboxone sublingual film

By David Salazar - 06/15/2018
The Food and Drug Administration has approved a generic sublingual film (Suboxone (buprenorphine and naloxone 4 mg/1 mg, 12 mg/3 mg, 2 mg/0.5 mg and 8 mg/2 mg) from Dr. Reddy’s Labs. The agency also approved Mylan’s generic Suboxone sublingual film in two dosage strengths — 8 mg buprenorphine/2 mg naloxone and 12 mg buprenorphine/3 mg naloxone).

Both companies’ products constitute the first FDA-approved generics of the opioid dependence treatment that uses an under-the-tongue delivery system. The product’s market for the 12 months ended April 2018 was $1.86 billion, according to IQVIA data.

The FDA said that the medications like generic Suboxone sublingual film play a key role in medication-assisted treatment for opioid dependence. MAT is part of the FDA’s five-point strategy to address the opioid crisis.

"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,” FDA commissioner Scott Gottlieb said. “That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”

Dr. Reddy’s generic was approved with a Risk Evaluation and Mitigation Strategy program.

“With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone® could not have come at a more critical time to help patients,” said Alok Sonig, Dr. Reddy’s CEO of developed markets. “We are excited to be launching this important product that will help enable patients to prevail over this insidious disease.”

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