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Friday, February 22, 2019

Mylan announces U.S. launch of generic Suboxone Sublingual Film

Mylan announced the U.S. launch of Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg, a generic version of Indivior’s Suboxone Sublingual Film. Mylan Pharmaceuticals received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. U.S. sales for Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg, were approximately $1.87B for the 12 months ending December 31, 2018, according to IQVIA

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