Research & Development
FDA Grants Lannett Approval for Dronabinol Capsules
23 May 2018 - - Philadelphia, Pennsylvania-based generic pharmaceuticals company Lannett Company, Inc. (NYSE: LCI) has received approval from the US Food and Drug Administration of its abbreviated new drug application for Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg, the therapeutic equivalent to the reference listed drug, MarinolCapsules 2.5 mg, 5 mg and 10 mg of AbbVie Inc., the company said.
For the 12 months ended March 2018, total US sales of Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg, was approximately USD 120m, according to IMS.
Tim Crew, chief executive officer of Lannett, said "We expect to commence marketing several products including Dronabinol Capsules over the course of this year. Currently, only a handful of manufacturers supply generic Dronabinol Capsules to the US market."
Lannett, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.
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