NORTHVALE, N.J., Aug. 10, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company")
(OTCBB:ELTP) today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration
(FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with
325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
“Oxycodone APAP is a strategic addition to Elite’s portfolio. It is an immediate release opioid product used
extensively by doctors today in pain management. The APAP creates irritation if the product is crushed and taken intranasally, and
so may provide some intranasal abuse-deterrence according to the FDA,” said Nasrat Hakim, President and CEO of Elite. “Elite is
committed to developing a diverse range of opioid abuse-deterrent products both using our proprietary technology and building a
foundation of attractive niche generic drugs. Elite also expects to file another generic opioid product this year.”
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 and OTC products which have been licensed to TAGI Pharma, Epic
Pharma and Valeant Pharmaceuticals International. Elite currently has eight commercial products being sold, additional approved
products pending manufacturing site transfer and the NDA for SequestOx™, for which it just received the CRL from the FDA. Elite’s
lead 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 also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem
Laboratories Ltd.). 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, the steps Elite
may take as a result of the CRL, the results of an End of Review Meeting and what actions the FDA may 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, intellectual property protections and defenses, and Elite’s ability to operate as
a going concern, 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
