Lannett has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg, the therapeutic equivalent to the reference listed drug, Marinol Capsules 2.5 mg, 5 mg and 10 mg of AbbVie Inc. For the 12 months ended March 2018, total U.S. sales of Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg, was approximately $120 million, according to IMS.
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"The approval of Dronabinol Capsules adds to our sizeable portfolio of near-term product opportunities," said Tim Crew, chief executive officer of Lannett. "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 U.S. market."