Sandoz launches Ciprofloxacin + Dexamethasone otic suspension in US for treatment of middle and outer ear bacterial infections

• Availability of this important medicine bolsters Sandoz industry-leading portfolio of high-quality, affordable antibiotics, which covers over 50 percent of the antibiotics available worldwide

• More than 80 percent of US children experience at least one ear infection by their third birthday¹

• Although ear infections primarily affect children, they can also affect adults, especially during the summer months due to increased water exposure^1,2

Princeton, New Jersey, August 10, 2020 — Sandoz Inc. today announced the US market introduction of Ciprofloxacin 0.3% + Dexamethasone 0.1% otic suspension 7.5mL ear drops for the treatment of middle ear and outer ear canal bacterial infections.

Ciprofloxacin + Dexamethasone otic suspension is an authorized generic of the Novartis medicine Ciprodex^® (ciprofloxacin and dexamethasone), otic suspension, and is administered via a controlled dispensing-tip bottle.

“The associates at Sandoz work hard to ensure the broadest portfolio of high-quality, affordable generic antibiotics is available to US patients. The important teamwork with our colleagues at Novartis Pharmaceuticals is a testament to our collective belief that cross-divisional collaboration will help increase patient access to high-quality healthcare,” said Carol Lynch, President, Sandoz Inc. “We are pleased to immediately offer the authorized generic version of this treatment for ear infections, including swimmer’s ear, which is common during the summer.”

In the US, ear infections are one of the most common reasons why young children go to the doctor³. More than 80 percent will experience at least one ear infection by their third birthday¹, and approximately 25 percent of all children will have repeat ear infections³.

Ciprofloxacin and dexamethasone combination ear drops is used in adults and children 6 months of age or older to treat certain types of bacterial infections in the ear. These bacterial infections include outer ear canal infection (known as acute otitis externa) and middle ear infection (known as acute otitis media) in people who have a tube in their eardrum known as a tympanostomy to prevent having too much fluid in the middle ear.

Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics and works by killing the bacteria or preventing their growth. Dexamethasone is a steroid medicine used to relieve the redness, itching, and swelling caused by ear infections.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Ciprofloxacin and dexamethasone otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.

Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections.

WARNINGS AND PRECAUTIONS

Ciprofloxacin and dexamethasone otic suspension is for otic use (ears) only, not for ophthalmic use, or for injection.

Hypersensitivity Reactions

Ciprofloxacin and dexamethasone otic suspension should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal, or facial edema), airway obstruction, dyspnea, urticaria, and itching.

Potential for Microbial Overgrowth with Prolonged Use

Prolonged use may result in overgrowth of non-susceptible, bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

Continued or Recurrent Otorrhea

If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

ADVERSE REACTIONS

Most commonly reported adverse reactions in clinical trials in AOM pediatric patients with tympanostomy tubes: ear discomfort (3.0%), ear pain (2.3%), ear precipitate (0.5%), irritability (0.5%), and taste perversion (0.5%).

Most commonly reported adverse reactions in clinical trials in AOE patients: ear pruritus (1.5%), ear debris (0.6%), superimposed ear infection (0.6%), ear congestion (0.4%), ear pain (0.4%), and erythema (0.4%)

Postmarketing adverse reactions include: auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.

Please see full Prescribing Information for additional safety information.

INDICATION

Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

Disclaimer

This media update 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 the investigational or approved products described in this media update, or regarding potential future revenues from such products. 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 the investigational or approved products described in this media update 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, if approved, such generic or biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products 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 generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2019 sales of USD 9.7 billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

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REFERENCES

1. National Institutes of Health. Ear Infections in Children. Available at: https://www.nidcd.nih.gov/health/ear-infections-children#1. Accessed June 16, 2020.

2. American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical Practice Guidelines. Acute Otitis Externa (Swimmer’s Ear). Available at: https://www.entnet.org/sites/default/files/AOEGuidelinePLSFinal.pdf. Accessed June 24, 2020.

3. Cleveland Clinic. Ear Infection (Otitis Media). Available at: https://my.clevelandclinic.org/health/diseases/8613-ear-infection-otitis-media. Accessed June 16, 2020.

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