Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Hydromorphone
January 26 2012 - 8:30AM
Elite Pharmaceuticals, Inc. ("Elite") (OTCBB:ELTP) announced today
that on January 23, 2012, the U.S. Food and Drug Administration
approved the Company's supplemental application for the
manufacturing and packaging of Hydromorphone Hydrochloride USP 8
mg. 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.
Hydromorphone hydrochloride is a member of the opioid analgesic
and antitussive class. It is a pure opioid agonist used primarily
for pain relief or as a cough suppressant. For the twelve
months ending September 2011, Dilaudid® 8 mg tablets and its
generic equivalents had total U.S. sales of approximately $30
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 four ANDA products with a sales and marketing partner;
one ANDA has launched, one ANDA has a pending launch, one ANDA is
in the process of a manufacturing site transfer and an additional
ANDA is currently under review by the FDA. Elite also
manufactures Lodrane D® and receives royalties for Lodrane D®, an
allergy product partnered with ECR Pharmaceuticals, a wholly owned
subsidiary of Hi-Tech Pharmacal. Elite's lead pipeline
products, ELI-216, a once-daily abuse resistant oxycodone, and
ELI-154, a once-daily oxycodone, are novel 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 has partnered with
Mikah Pharma to develop a new product and with Hi-Tech Pharmacal to
develop an intermediate for a generic product. 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, including
those related to the preliminary nature of the clinical program
results and the potential for further product development, that
involve known and unknown risks, delays, uncertainties and other
factors not under the control of Elite, which may cause actual
results, performance or achievements of the companies to be
materially different from the results, performance or other
expectations implied by these forward-looking statements. In
particular, because substantial future testing will be required
prior to approval, the results described above may not be supported
by additional data or by the results of subsequent trials. These
risks and other factors, including 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 such as
the 10K, 10Q and 8K reports. 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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