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Elite Pharmaceuticals, Inc.: Elite Pharmaceuticals and SunGen Pharma Receive FDA Approval for Generic Adderall XR(R)
?December 12, 2019, 6:55 AM EST
NORTHVALE, NJ / ACCESSWIRE / December 12, 2019 / Elite
Pharmaceuticals, Inc. ("Elite" or the "Company") (ELTP), a specialty pharmaceutical company developing its own generic products, partnered generic products and proprietary abuse-deterrent opioids, today announced that it received approval from the US Food and Drug Administration (FDA) for a generic version of Adderall XR®, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). According to IQVIA (formerly QuintilesIMS Health) data, the branded product and its equivalents had total U.S. sales of $1.3 billion for the twelve months ending October 2019.
Generic Adderall XR is jointly owned and the second product approval for our Elite and SunGen Pharma LLC ("SunGen") collaboration. Elite will manufacture and package the product on a cost-plus basis. Lannett Company, Inc. will be the exclusive U.S. distributor.
"We are pleased to have received approval of this second product co-developed with our partner, SunGen," said Nasrat Hakim, President and CEO of Elite. "Launch of this product is our top priority."
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"We are very pleased to have another ANDA approval through our partnership with Elite and achieve a significant milestone for Sungen as we work on the launch of the recently approved generic Adderall XR®," said Dr. Jim Huang, Co-CEO of SunGen.
About Lannett Company, Inc.
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