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FDA approves Lannett's Buprenorphine and Naloxone sublingual tablets

  • Lannett Company (NYSE:LCI) announces that it received approval from the FDA for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, for the treatment of opioid addiction, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg.
  • According to IMS, total U.S. sales of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg were ~$270M in 2015.
  • The product, a Class III controlled substance, received FDA approval under an approved Risk Evaluation and Mitigation Strategy (REMS).

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Lannett Company, Inc.