FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®
(Thomson Reuters ONE) -
Novartis International AG /
FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®
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The issuer is solely responsible for the content of this announcement.
* FDA accepts Sandoz ANDA for substitutable generic version of Advair
Diskus(®)
* Sandoz believes its combination product will offer asthma and COPD patients
same safety and efficacy as reference medicine
* Sandoz looks forward to working with FDA to drive access to this treatment
option
Holzkirchen, June 15, 2017- Sandoz today announced that the US Food and Drug
Administration (FDA) has accepted its Abbreviated New Drug Application for
fluticasone propionate / salmeterol combination product, a substitutable generic
version of Advair Diskus(®)[1].
If approved, the product will treat asthma in patients aged four years and
older, in addition to providing maintenance treatment of airflow obstruction and
reducing exacerbations in patients with chronic obstructive pulmonary disease
(COPD).
"Sandoz scientists and medical experts have developed a high-quality generic
option that we believe offers asthma and COPD patients the same safety and
efficacy that they expect from Advair Diskus(®)," said Peter Goldschmidt,
President of Sandoz Inc.
"We know the treatment of asthma and COPD place a significant cost burden on
patients and the healthcare system in the US. We are confident in our
application and data, and we look forward to working with the FDA to provide
greater access and affordability for this treatment option."
Sandoz, a global leader in generic pharmaceuticals and biosimilars, acquired
Oriel Therapeutics, Inc. in 2010, gaining additional expertise in the
development of orally inhaled medicines.
[1] Advair Diskus(®) is a registered trademark of Glaxo Group Limited.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "believes," "will," "looks forward," "drive," "believe,"
"confident," "look forward," or similar terms, or by express or implied
discussions regarding potential future product approvals or launches, or
regarding potential revenues from our generic fluticasone propionate/ salmeterol
product. You should not place undue reliance on these statements. Such forward-
looking statements are based on the current beliefs and expectations of
management regarding future events, and are subject to significant known and
unknown risks and uncertainties. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the forward-looking
statements. There can be no guarantee that our generic fluticasone propionate/
salmeterol product will be commercially successful in the future. In particular,
management's expectations could be affected by, among other things, regulatory
actions or delays or government regulation generally; competition in general,
including potential approval of additional versions of generic fluticasone
propionate/ salmeterol products for sale; government, industry and general
public pricing and reimbursement pressures; patent litigation outcomes; safety,
quality or manufacturing issues; general economic and industry conditions, and
other risks and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Novartis is providing the
information in this press release as of this date and does not undertake any
obligation to update any forward-looking statements contained in this press
release as a result of new information, future events or otherwise.
About Sandoz
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a
division of the Novartis Group, our purpose is to discover new ways to improve
and extend people's lives. We contribute to society's ability to support growing
healthcare needs by pioneering novel approaches to help people around the world
access high-quality medicine. Our portfolio of approximately 1000 molecules,
covering all major therapeutic areas, accounted for 2016 sales of USD 10.1
billion. In 2016, our products reached more than 500 million patients and we
aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in
Germany's Greater Munich area.
Sandoz is on Twitter. Sign up to follow (at)Sandoz_global at
http://twitter.com/Sandoz_Global.
###
For further information, contact:
Novartis Media Relations Novartis Global Media Relations
Central media line: +41 61 324 2200 Eric Althoff
media.relations(at)novartis.com +41 61 324 7999
eric.althoff(at)novartis.com
Sandoz Global Communications Sandoz Global Communications
Duncan Cantor Chris Lewis
+49 170 650 6067 +49 8024 476 1906
duncan.cantor(at)sandoz.com chris.lewis(at)sandoz.com
Sandoz US Communications Sandoz US Communications
Leslie Pott Philip Martucci
+1 609 627 5287 +1 609 627 8730
leslie.pott(at)sandoz.com philip.martucci(at)sandoz.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2407
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Press release (PDF):
http://hugin.info/134323/R/2113674/804092.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 15.06.2017 - 20:00 Uhr
Sprache: Deutsch
News-ID 548270
Anzahl Zeichen: 6886
contact information:
Town:
Basel
Kategorie:
Business News
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