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PHILADELPHIA — Lannett Co. has received Food and Drug Administration approval for its 505(b)(2) New Drug Application (NDA) for morphine sulfate oral solution.
Lannett said Friday that it expects to begin shipping the pain relief drug soon.
"This is first drug approval Lannett has received using a 505(b)(2) application," Arthur Bedrosian, president and chief executive officer of Lannett, said in a statement. "We applaud the dedicated efforts or our team and thank our shareholders for their patience and faith in our ability to relaunch this important medication."
A narcotic medication for moderate to severe pain, morphine sulfate oral solution totaled sales of about $31.7 million for the last 12 months at average wholesale prices, according to Wolters Kluwer data reported by Lannett.
