February 21, 2019 PR-M02-19-NI-045
PRINCETON, N.J. /PRNewswire/ -- Sandoz Inc., a Novartis division, today announced that the authorized generic of SUBOXONE® 1 (buprenorphine and naloxone) Sublingual Film (CIII) by Indivior Inc. in all four dosage strengths is immediately available in the US.
Sandoz buprenorphine and naloxone sublingual film (2mg/0.5mg, 4mg/1mg, 8mg/2mg and 12mg/3mg) is indicated for the treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
"We are excited to have the opportunity to further increase access to this critical medicine in the US market and to be a part of the solution to a healthcare crisis that the nation is facing," said Carol Lynch, President of Sandoz Inc. "Sandoz is well-positioned to deliver another important treatment alternative for patients suffering from addiction."
As part of this effort, Sandoz is commercializing FDA-cleared prescription digital therapeutics as an adjunct to outpatient treatment to help patients with substance use disorder and opioid use disorder. Sandoz is also working with other partners and healthcare professionals to help address substance and opioid abuse, which requires a collaborative effort between all stakeholders, including regulatory authorities, physicians and other healthcare providers.
According to IQVIA, US sales for SUBOXONE were approximately USD 2 billion for the period ending December 2018(MAT: Moving Annual Target).
1 SUBOXONE is a registered trademark of Indivior UK Limited.
Important Safety Information
Contraindications
Hypersensitivity to buprenorphine or naloxone.
Warnings and Precautions
Adverse Reactions
Adverse events commonly observed with the sublingual/buccal administration of the buprenorphine and naloxone sublingual film were oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
Drug Interactions
Use in Specific Populations
Full prescribing information is available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a5edcf9-828c-4f97-b671-268ab13a8ecd.
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 "drive," "potential," "well-positioned," "can," "will," "plan," "expected," "anticipate," "look forward," "believe," "commitment," "investigational," "pipeline," "portfolio," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, launches, new indications or labeling for authorized generic Buprenorphine & Naloxone sublingual film 8mg/2mg and the other 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. Nor can there be any guarantee that authorized generic Buprenorphine & Naloxone sublingual film 8mg/2mg or the other investigational or approved products described in this release 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 competing versions of such products; 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.
Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/Sandoz_Global.
For further information, contact: |
||||
Leslie Pott Sandoz US Communications |
Chris Lewis Sandoz Global Communications +49 8024 476 1906 |
Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications
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 broad portfolio, covering all major therapeutic areas, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.