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.”
About SunGen Pharma LLC
SunGen Pharma, LLC is a privately held specialty pharmaceutical company which develops, contract manufactures, and sells
pharmaceutical finished products. SunGen specializes in the development of oral solid extended release and complex injectable
products. SunGen has business partnerships with many US-based generic pharmaceutical companies to develop, manufacture, and sell
several pharmaceutical products in the US.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which is developing a pipeline of proprietary pharmacological
abuse-deterrent opioid products as well as niche generic products. Elite specializes in oral sustained and controlled release
drug products which have high barriers to entry. Elite owns generic products which have been licensed to TAGI Pharma and
Glenmark Pharmaceuticals, Inc., USA. Elite currently has twelve approved generic products, three generic products filed with the
FDA, two approved generic products pending manufacturing site transfer, and an NDA filed for SequestOx™. Elite’s pipeline products
include abuse-deterrent opioids which utilize the Company’s patented proprietary technology and a once-daily opioid. These
products include sustained release oral formulations of opioids for the treatment of chronic pain. These formulations are intended
to address two major limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and
deterrence of potential opioid abuse. Elite operates a GMP and DEA registered facility for research, development, and manufacturing
located in Northvale, NJ. Learn more at www.elitepharma.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may
have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements
involve risks and uncertainties including, without limitation, Elite’s ability to obtain FDA approval of the transfers of the ANDAs
or the timing of such approval process, delays, uncertainties, inability to obtain necessary ingredients and other factors not
under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from
the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking
statements may include statements regarding the expected timing of approval, if at all, of SequestOx™ by the FDA, and the actions
the FDA require of Elite in order to obtain approval of the NDA. These forward-looking statements are not guarantees of future
action or performance. These risks and other factors, including, without limitation, Elite’s ability to obtain sufficient funding
under the LPC Agreement or from other sources, the timing or results of pending and future clinical trials, regulatory reviews, and
approvals by the Food and Drug Administration and other regulatory authorities and intellectual property protections and defenses,
are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K.
Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future
events or otherwise.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
