Elite Pharmaceuticals, Inc. : ELITE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL APPLICATION FOR HYDROMORPHONE
January 26, 2012 at 09:02 am
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Elite Pharmaceuticals Press Release for: Thursday,
January 26, 2012
ELITE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF
SUPPLEMENTAL APPLICATION FOR HYDROMORPHONE
Northvale, New Jersey, Thursday, January 26, 2012:
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.
Contact:
For Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
www.elitepharma.com
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.
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Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops and distributes niche generic products. The Company specializes in developing and manufacturing oral, controlled-release drug products. It owns multiple generic products which has been licensed to Prasco, LLC and TAGI Pharma. The Companyâs segments include Abbreviated New Drug Applications (ANDA) and New Drug Application (NDA). The Companyâs products include Phentermine HCl 37.5mg tablets, Loxapine Succinate 5mg, 10mg, 25mg and 50gm capsules, Phentermine HCl 15mg and 30mg capsules, Naltrexone HCl 50mg tablets, Dantrolene Sodium Capsules 25mg, 50mg and 100mg, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg tablets, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg capsules and others.