Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for
NORTHVALE, N.J., Feb. 6, 2013 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc.
("Elite") (OTCBB:ELTP) announced today that on January 31, 2012, the U.S. Food
and Drug Administration approved the Company's supplemental application for
the manufacturing and packaging of naltrexone hydrochloride 50 mg tablets.
This approval will allow the Company to commence the commercial manufacturing
and packaging of this product for its sales and marketing partner, which will
distribute the product as part of a multi-product distribution agreement.
Naltrexone is an opioid receptor antagonist used primarily in the management
of alcohol dependence and opioid addiction.For the twelve months ending
December 31, 2012, Revia® and its generic equivalents had total U.S. sales of
approximately $16 million according to IMS Health Data.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release
products. Elite's strategy includes assisting partner companies in the life
cycle management of products to improve off-patent drug products and
developing generic versions of controlled release drug products with high
barriers to entry. Elite has five commercial products with two additional
products under review, pending approval by the FDA. Elite's lead pipeline
products include abuse resistant opioids utilizing the Company's patented
proprietary technology, and a once-daily opioid.They are sustained release
oral formulations of opioids for the treatment of chronic pain, which address
two of the limitations of existing oral opioids: the provision of consistent
relief of baseline pain levels and deterrence of potential abuse.Elite also
provides contract manufacturing for Actavis and Ascend Laboratories
(previously a subsidiary of ThePharmaNetwork and now a subsidiary of Alkem
Laboratories Ltd.) and has partnered with Mikah Pharma to develop a new
product, with Hi-Tech Pharmacal to develop an intermediate for a generic
product, and a Hong Kong based company to develop a branded product for the
United States market and its territories.Elite operates a GMP and DEA
registered facility for research, development, and manufacturing located in
The Elite Pharmaceuticals, Inc. logo is available at
This news 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, 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
risks and other factors, including, without limitation, 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 the Company'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
undertakes no obligation to update any forward-looking statements.
CONTACT: For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Elite Pharmaceuticals, Inc Logo
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