Sandoz Inc. announces US FDA approval of pediatric dose of SYMJEPI™ (epinephrine)

Princeton, New Jersey, September 27, 2018 – Sandoz Inc. today announced that the US Food and Drug Administration has approved SYMJEPI™ (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children.

Sandoz will distribute and commercialize SYMJEPI™ (epinephrine) 0.15 mg Injection, as well as SYMJEPI 0.3 mg Injection, in the US under an exclusive agreement with Adamis Pharmaceuticals Corporation.

SYMJEPI 0.15 mg Injection is indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis. SYMJEPI 0.15 mg Injection is intended for immediate administration in patients who weigh between 33 and 65 pounds and who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

“Today’s approval of SYMJEPI in the pediatric setting is a huge step forward to treat children at increased risk for anaphylaxis as it represents an affordable alternative to current treatment offerings at a time when patients need access to this medicine most,” said Carol Lynch, President of Sandoz Inc. “We are committed to reimagining their care by bringing this valuable, life-saving medicine in a pre-filled epinephrine syringe to the US market as soon as possible.” 

Important Safety Information

Full prescribing information is available at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b414a33-7371-4801-ae16-59db8c7b1aab

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for SYMJEPI, or regarding potential future revenues from SYMJEPI. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 SYMJEPI will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that SYMJEPI will be commercially successful in the future. In particular, our expectations regarding SYMJEPI could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional competitive versions of this product; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

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