Sandoz generic injectable acetaminophen immediately available to US patients, strategically building hospital portfolio offering

• Acetaminophen injection used in patients 2 years and older to treat mild to moderate pain, moderate to severe pain in conjunction with opioid analgesics, or to reduce fever¹

• Provides US healthcare system a more affordable treatment option for a key medicine stocked in every US hospital and clinic

• Launch aligns with Sandoz strategy, expanding injectables portfolio and bringing affordable, high-quality medicines to US patients in hospitals

Princeton, December 8, 2020 — Sandoz Inc. today announced the immediate availability in the US of its generic acetaminophen injection, used in adult and pediatric patients two years and older to relieve mild to moderate pain and to treat moderate to severe pain in conjunction with opioid analgesics. It can also be used to reduce fever.

Acetaminophen is the most commonly taken pain medicine worldwide and is recommended by the World Health Organization as first line-therapy in pain conditions.

“At Sandoz, we are continuously growing our injectable medicines portfolio to ensure patients across the US have access to important medicines when they need them, especially in the hospital setting,” said Carol Lynch, President, Sandoz Inc. “Through the launch of our generic injectable acetaminophen, we are offering a high-quality, affordable alternative to opioids, helping to mitigate our country’s opioid addiction crisis.”

Sandoz is commercializing its generic injectable acetaminophen, available as 100 mL glass vial containing 1,000 mg acetaminophen (10 mg/mL), which was developed by Milla Pharmaceuticals, member of the Alter Pharma Group. Alter Pharma is a Belgian group of pharmaceutical companies that distributes a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and retirement homes.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Acetaminophen is contraindicated:

• In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation.
• In patients with severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

• Administration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen-containing products including combination products) may result in hepatic injury, including the risk of liver failure and death.
• Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance £30 mL/min).
• Discontinue acetaminophen immediately at the first appearance of skin rash and if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy.
• Take care when prescribing, preparing, and administering acetaminophen injection to avoid dosing errors which could result in accidental overdose and death.

ADVERSE REACTIONS

The most common adverse reactions in patients treated with acetaminophen were nausea, vomiting, headache, and insomnia in adult patients; nausea, vomiting, constipation, and pruritus in pediatric patients.

DRUG INTERACTIONS

• Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential.
• Chronic oral acetaminophen use at a dose of 4000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.

USE IN SPECIFIC POPULATIONS

• Pediatric Use: The effectiveness of acetaminophen for the treatment of acute pain in pediatric patients younger than 2 years of age has not been established. The safety and effectiveness of acetaminophen in pediatric patients is supported by evidence from adequate and well controlled studies in adults with additional safety and pharmacokinetic data for this age group.
• Geriatric Use: No overall differences in safety or effectiveness were observed between geriatric and younger subjects.
• Hepatic Impairment: Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease.
• Renal Impairment: In cases of severe renal impairment, longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted.

Please see full Prescribing Information for additional safety information.

INDICATIONS

Acetaminophen injection is indicated for the

• Management of mild to moderate pain in adult and pediatric patients 2 years and older
• Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
• Reduction of fever in adult and pediatric patients

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,” “may,” “could,” “would,” “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 press release, 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 press release 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, data integrity 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, 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 need. 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.

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CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

References

1. Acetaminophen Injection. Prescribing information. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3b4ab1cf-8642-44f5-b3a2-3f1f7c620ce9

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