This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a
VIMOVO (naproxen/esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole magnesium, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. VIMOVO is not interchangeable with the individual components of naproxen and esomeprazole magnesium.
VIMOVO is not recommended for use in children younger than 18 years of age. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond six months. VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider. For Full Prescribing Information please see www.VIMOVO.com.
Important Safety Information
VIMOVO is not right for everyone, including patients who have had an asthma attack, hives or other allergic reaction with aspirin or any other NSAID medicine, patients who are allergic to any of the ingredients in VIMOVO or women in late stages of pregnancy.
Serious allergic reactions, including skin reactions, can occur without warning and can be life-threatening; discontinue use of VIMOVO at the first appearance of a skin rash or if you develop sudden wheezing; swelling of the lips, tongue or throat; fainting or problems swallowing.
VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.
Tell your health care provider right away if you develop signs of active bleeding from any source.
VIMOVO can lead to onset of new hypertension or worsening of existing high blood pressure, either of which may contribute to an increased risk of a heart attack or stroke.
Speak with your health care provider before starting VIMOVO if you
Tell your doctor about all of the medicines you take, prescription and non-prescription drugs, including clopidogrel, vitamins and herbal supplements. VIMOVO may affect how other medicines work and other medicines may affect how VIMOVO works.
VIMOVO may increase your risk of getting severe diarrhea. Call your doctor right away if you have watery stool, stomach pain and fever that does not go away.
Talk to your health care provider about your risk for bone fractures and developing low levels of magnesium if you take VIMOVO for a long period of time.
Talk to your health care provider about your risk for developing low levels of magnesium if you take VIMOVO for a long period of time.
The most common side effects of VIMOVO include: inflammation of the lining of the stomach, indigestion, diarrhea, stomach ulcers, abdominal pain and nausea.
About Horizon Pharma plc
Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets 11 medicines through its orphan, rheumatology and primary care business units. For more information, please visit www.horizonpharma.com. Follow @HZNPplc on Twitter or view careers on our LinkedIn page.
This press release contains forward-looking statements, including statements regarding the issuance of a patent based on the Notice of Allowance from the
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