Elite Pharmaceuticals Inc (ELTP)

[The ELTP King]

***** Elite Pharmaceuticals and SunGen Pharma Receive FDA Approval for Generic Adderall® *****

NORTHVALE, N.J., Dec. 10, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for a generic version of Adderall®, an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 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) and Narcolepsy. According to QVIA (formerly QuintilesIMS Health) data the branded product and its equivalents had total U.S. sales of $365 million for the twelve months ending September 30, 2018.
This is the first product approval for our Elite and SunGen Pharma LLC ("SunGen") collaboration. The product is jointly owned. Elite will manufacture and package the product on a cost-plus basis and the parties are negotiating an agreement for sales of the product.

"This approval represents the first of many products being co-developed with our partner, SunGen," said Nasrat Hakim, President and CEO of Elite. "This is the fifth product approval for Elite in 2018 and we have three ANDAs still pending with the FDA in addition to our SequestOx™ NDA filing."

"We are pleased to receive the first approval for a co-developed product with our partner, Elite," said Dr. Jim Huang, Co-CEO of SunGen. "And we look forward to additional approvals in 2019."

Generic Adderall could be listed on the FDA website as soon as 8 hours.

I will refresh my screen at 4:00 am local time.

Thanks.