Teva Announces FDA Acceptance of sNDA for a Higher Concentration Dose of COPAXONE® Given Three Times a Week
30 Mai 2013 - 2:02PM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today
that the U.S. Food and Drug Administration (FDA) has accepted for
review the company’s supplemental new drug application (sNDA) for
COPAXONE® (glatiramer acetate injection) 40mg/ 1mL, a higher
concentration dose of COPAXONE® that offers a less frequent three
times a week dosing regimen administered subcutaneously for
patients with relapsing-remitting multiple sclerosis (RRMS).
Currently, the approved dose for COPAXONE® is 20 mg/ 1mL, which is
a once a day subcutaneous injection.
"We are pleased that the FDA has accepted for review our sNDA.
If approved, COPAXONE® 40mg/ 1mL given three times weekly will
offer patients and their physicians flexibility in choosing a
dosing regimen that works best for them, built upon the proven
efficacy and established safety track record that COPAXONE®
offers," said Michael Hayden, M.D., President of Global R&D and
Chief Scientific Officer, Teva Pharmaceuticals Industries Ltd.
“With a strong heritage in MS research innovation, Teva continues
to demonstrate its commitment to patients by developing new
treatment options to benefit the RRMS community.”
About COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for
the reduction of the frequency of relapses in relapsing-remitting
multiple sclerosis, including patients who have experienced a first
clinical episode and have MRI features consistent with multiple
sclerosis. The most common side effects of COPAXONE® are
redness, pain, swelling, itching, or a lump at the site of
injection, flushing, rash, shortness of breath, and chest pain. See
additional important information
at: http://www.sharedsolutions.com/redirect/PrescribingInformation.pdf.
For hardcopy releases, please see enclosed full prescribing
information. COPAXONE® is now approved in more than 50
countries worldwide, including the United States, Russia, Canada,
Mexico, Australia, Israel, and all European countries.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading
global pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000 molecules
and a direct presence in about 60 countries. Teva's branded
businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently
employs approximately 46,000 people around the world and reached
$20.3 billion in net revenues in 2012.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express
the current beliefs and expectations of management. Such statements
are based on management’s current beliefs and expectations and
involve a number of known and unknown risks and uncertainties that
could cause our future results, performance or achievements to
differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products, competition for our innovative
products, especially Copaxone® (including competition from
innovative orally-administered alternatives, as well as from
potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and
as a result of increased governmental pricing pressures),
competition for our specialty pharmaceutical businesses, our
ability to achieve expected results through our innovative R&D
efforts, the effectiveness of our patents and other protections for
innovative products, decreasing opportunities to obtain U.S. market
exclusivity for significant new generic products, our ability to
identify, consummate and successfully integrate acquisitions, the
effects of increased leverage as a result of recent acquisitions,
the extent to which any manufacturing or quality control problems
damage our reputation for high quality production and require
costly remediation, our potential exposure to product liability
claims to the extent not covered by insurance, increased government
scrutiny in both the U.S. and Europe of our agreements with brand
companies, potential liability for sales of generic products prior
to a final resolution of outstanding patent litigation, including
that relating to the generic version of Protonix®, our exposure to
currency fluctuations and restrictions as well as credit risks, the
effects of reforms in healthcare regulation and pharmaceutical
pricing and reimbursement, any failures to comply with complex
Medicare and Medicaid reporting and payment obligations,
governmental investigations into sales and marketing practices
(particularly for our specialty pharmaceutical products),
uncertainties surrounding the legislative and regulatory pathways
for the registration and approval of biotechnology-based products,
adverse effects of political or economical instability, corruption,
major hostilities or acts of terrorism on our significant worldwide
operations, interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex
manufacturing processes, any failure to retain key personnel or to
attract additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers,
variations in patent laws that may adversely affect our ability to
manufacture our products in the most efficient manner, potentially
significant impairments of intangible assets and goodwill,
potential increases in tax liabilities, the termination or
expiration of governmental programs or tax benefits, environmental
risks and other factors that are discussed in our Annual Report on
Form 20-F for the year ended December 31, 2012 and in our other
filings with the U.S. Securities and Exchange Commission.
Forward-looking statements speak only as of the date on which they
are made and the Company undertakes no obligation to update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
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