Lannett (LCI) Says Buprenorphine and Naloxone Sublingual Tablets NDA Approved by FDA
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Lannett Announces Approval For Buprenorphine And Naloxone Sublingual Tablets, 2 mg/0.5 mg And 8 mg/2 mg
September 20, 2016 6:56 AM EDTPHILADELPHIA, Sept. 20, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, 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 in 2015 of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, at Average Wholesale Price (AWP) were approximately $270 million. ... More