Elite Pharmaceuticals Inc. (OTC:ELTP) shook off the negatives of Monday’s session, by posting positive numbers on exciting news.
The company, based out of Northvale, New Jersey, announced that it received approval from the U.S. Food and Drug Administration (FDA) for a generic version of Adderall®
Adderall is an immediate-release mixed salt of a single entity Amphetamine product of varying strengths, which acts a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
According to industry data, the branded product and its equivalents had total U.S. sales of $365 million for the 12 months ending with September.
This is the first product approval for our Elite and SunGen Pharma LLC 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.
Said Elite CEO Nasrat Hakim, "This approval represents the first of many products being co-developed with our partner, SunGen.“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."
Shares in Elite gained 86-100ths of a cent Monday towards the close, or 1%, to 8.486 cents, on volume of 772,000.
