Le Lézard
Classified in: Health
Subject: FDA

Lannett Receives FDA Approval For Dronabinol Capsules


PHILADELPHIA, May 21, 2018 /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 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. 

Lannett Logo (PRNewsFoto/Lannett Company, Inc.)

"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." 

About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.  For more information, visit the company's website at www.lannett.com.

This news release contains certain statements of a forward-looking nature relating to future events or future business performance.  Any such statement, including, but not limited to, successfully commercializing Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg, and the planned launches of other products, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC.  These forward-looking statements represent the Company's judgment as of the date of this news release.  The Company disclaims any intent or obligation to update these forward-looking statements.

Contact:   
Robert Jaffe 
Robert Jaffe Co., LLC 
(424) 288-4098

SOURCE Lannett Company, Inc.


These press releases may also interest you

at 11:45
SummaryProduct: Henna cones Issue: Chemical hazard / Product safety What to do: Stop using and selling them immediately and dispose of them in regular household garbage Who this is for: General public / Industry; Retail, Importers IssueHealth Canada...

at 11:30
The "Global Antibody Therapeutic Market: Focus on Format, Disease Area, Route of Administration, End Users, Region, and Competitive Landscape - Analysis and Forecast, 2024-2033" report has been added to  ResearchAndMarkets.com's offering. The global...

at 11:30
XtalPi Inc., a leading global technology company in integrating artificial intelligence (AI) and robotics to advance the discovery of groundbreaking medicine and innovative materials, announced today the launch of its proprietary comprehensive solid...

at 11:25
Manifest Technologies, Inc., developer of an AI-powered computational neuro-imaging platform for CNS disease, today unveiled the company after completing its initial funding and partnership with a top five global pharmaceutical company. Today, over...

at 11:08
Sunwave Health, a leader in healthcare technology, proudly announces the launch of MARA, a patent-pending, innovative AI Agent designed to transform the landscape of behavioral health documentation. Since its launch on October 25, 2023, MARA has...

at 11:04
MelliCell Inc. has been awarded a U.S. National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for $275,000 to conduct research and development (R&D) work on "Industrial Scale Technology for Drug Development in Mature Human...



News published on and distributed by: