Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Naltrexone
February 06 2013 - 8:00AM
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 Northvale, NJ.
The Elite Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8737
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
Dianne@elitepharma.com
www.elitepharma.com
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