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Thursday, 15 June 2017

FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®

Novartis International AG    

FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus®

  • 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 @Sandoz_global at http://twitter.com/Sandoz_Global.

 

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For further information, contact:

 

Novartis Media Relations

Central media line: +41 61 324 2200

media.relations@novartis.com

 

Novartis Global Media Relations

Eric Althoff

+41 61 324 7999

eric.althoff@novartis.com

Sandoz Global Communications

Duncan Cantor
+49 170 650 6067
duncan.cantor@sandoz.com

Sandoz Global Communications

Chris Lewis

+49 8024 476 1906

chris.lewis@sandoz.com

Sandoz US Communications

Leslie Pott
+1 609 627 5287

leslie.pott@sandoz.com

Sandoz US Communications

Philip Martucci

+1 609 627 8730

philip.martucci@sandoz.com

 

 

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@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)



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: Novartis International AG, P.O. Box, Basel CH-4002, Switzerland
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