Welcome to the Shroomery Message Board! You are experiencing a small sample of what the site has to offer. Please login or register to post messages and view our exclusive members-only content. You'll gain access to additional forums, file attachments, board customizations, encrypted private messages, and much more!
|
 roxiwally
teachmetoroxi
Registered: 09/30/09
Posts: 173
Loc: Northern California
Last seen: 8 months, 11 days
|
 FDA approves new Fentanyl formulation 
#11497503 - 11/21/09 10:05 AM (3 years, 5 months ago) |
|
|
http://www.reuters.com/article/pressRelease/idUS233737+30-Oct-2009+BW20091030
T. LOUIS--(Business Wire)--
Covidien (NYSE: COV), a leading global provider of healthcare products, today
announced that its subsidiary, Mallinckrodt Inc., has received U.S. Food and
Drug Administration (FDA) approval of its Abbreviated New Drug Application
(ANDA) for Oral Transmucosal Fentanyl Citrate (CII).
Covidien`s product is a generic alternative to the branded ACTIQ®. It is a solid
formulation of fentanyl that resembles a lozenge on a handle. Oral Transmucosal
Fentanyl Citrate, a Class II controlled substance, is an opioid
analgesicindicated only for the management of breakthrough cancer pain in
patients 16 years of age and older with malignancies who are already receiving
and who are tolerant to opioid therapy for their underlying, persistent cancer
pain.
"Pain is one of the most common reasons patients consult a physician, yet it is
often inadequately treated," said Herbert Neuman, M.D., Chief Medical Officer,
Pharmaceuticals, Covidien. "We are pleased to receive this FDA approval and to
introduce this treatment option to meet patients` needs."
Covidien expects to launch Oral Transmucosal Fentanyl Citrate in the U.S. in
early calendar 2010, in 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,200 mcg and 1,600
mcg strengths. The launch will be accompanied by an extensive risk management
plan to help ensure the appropriate and safe use of this medication.
"Covidien continues to build on its extensive pain treatment experience by
focusing on providing patients with access to advanced medications," said
Timothy R. Wright, President, Pharmaceuticals, Covidien.
Covidien is the largest supplier of controlled pain medications in the United
States based on number of prescriptions.
ABOUT ORAL TRANSMUCOSAL FENTANYL CITRATE
WARNINGS: IMPORTANCE OF PROPER PATIENT SELECTION and POTENTIAL FOR ABUSE
Oral Transmucosal Fentanyl Citrate(OTFC) contains fentanyl, an opioid agonist
and a Schedule II controlled substance, with an abuse liability similar to other
opioid analgesics. OTFC can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when prescribing or
dispensing OTFC in situations where the physician or pharmacist is concerned
about an increased risk of misuse, abuse or diversion. Schedule II opioid
substances which include morphine, oxycodone, hydromorphone, oxymorphone, and
methadone have the highest potential for abuse and risk of fatal overdose due to
respiratory depression.
OTFC is indicated only for the management of breakthrough cancer pain in
patients with malignancies who are already receiving and who are tolerant to
opioid therapy for their underlying persistent cancer pain. Patients considered
opioid tolerant are those who are taking at least 60 mg morphine/day, at least
25 mcg transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8
mg oral hydromorphone daily or an equianalgesic dose of another opioid for a
week or longer.
OTFC is intended to be used only in the care of cancer patients and only by
oncologists and pain specialists who are knowledgeable of and skilled in the use
of Schedule II opioids to treat cancer pain.
Because life-threatening hypoventilation could occur at any dose in patients not
taking chronic opiates, OTFC is contraindicated in the management of acute or
postoperative pain. This product must not be used in opioid non-tolerant
patients.
Patients and their caregivers must be instructed that OTFC contains a medicine
in an amount which can be fatal to a child. All units must be kept out of the
reach of children and opened units properly discarded.
The concomitant use of OTFC with strong and moderate cytochrome P450 3A4
inhibitors may result in an increase in fentanyl plasma concentrations, and may
cause potentially fatal respiratory depression.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative
medical solutions for better patient outcomes and delivers value through
clinical leadership and excellence. Covidien manufactures, distributes and
services a diverse range of industry-leading product lines in three segments:
Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of $10
billion, Covidien has more than 41,000 employees worldwide in 59 countries, and
its products are sold in over 140 countries. Please visit www.covidien.com to
learn more about our business.
ACTIQ is a registered trademark of Anesta Corporation.
Forward-Looking Statements
Any statements contained in this communication that do not describe historical
facts may constitute forward-looking statements as that term is defined in the
Private Securities Litigation Reform Act of 1995. Any forward-looking statements
contained herein are based on our management's current beliefs and expectations,
but are subject to a number of risks, uncertainties and changes in
circumstances, which may cause actual results or Company actions to differ
materially from what is expressed or implied by these statements. The factors
that could cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to effectively
introduce and market new products or keep pace with advances in technology, the
reimbursement practices of a small number of large public and private insurers,
cost-containment efforts of customers, purchasing groups, third-party payers and
governmental organizations, intellectual property rights disputes, complex and
costly regulation, including healthcare fraud and abuse regulations,
manufacturing or supply chain problems or disruptions, rising commodity costs,
recalls or safety alerts and negative publicity relating to Covidien or its
products, product liability losses and other litigation liability, including
legacy Tyco-related litigation, divestitures of some of our businesses or
product lines, our ability to execute strategic acquisitions of, investments in
or alliances with other companies and businesses, competition, risks associated
with doing business outside of the United States, foreign currency exchange
rates, issues related to our existing material weakness in accounting for income
taxes or potential environmental liabilities. These and other factors are
identified and described in more detail in our filings with the SEC. We disclaim
any obligation to update these forward-looking statements other than as required
by law.
Covidien
JoAnna Schooler, 314-654-3543
Director, Communications
joanna.schooler@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President, Investor Relations
cole.lannum@covidien.com
or
Erica Abbett, 314-654-3247
Manager, Media Relations
erica.abbett@covidien.com
or
Brian Nameth, 508-452-4363
Director, Investor Relations
brian.nameth@covidien.com
| |
|
|
You cannot start new topics / You cannot reply to topics
HTML is disabled / BBCode is enabled
Moderator: Alan Rockefeller
485 topic views. 5 members, 18 guests and 2 web crawlers are browsing this forum.
[ Toggle Favorite | Print Topic ]
| | |
|
|
|
Images only 
Threaded
Previous
Index
Next
Edit 
Reply 
