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Horizon Pharma Announces FDA Approval Of RAYOS® (prednisone) Delayed-Release Tablets For Rheumatoid Arthritis And Multiple Additional Indications

Outside the United States, LODOTRA is approved for the treatment of moderate to severe active RA when accompanied by morning stiffness in 16 European countries and Israel.  Horizon has granted commercialization rights for LODOTRA in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited.

Important Safety Information

RAYOS ® (prednisone) delayed release tablets

Approved uses of RAYOS

RAYOS, a delayed‐release form of prednisone, prevents the release of substances in the body that cause inflammation.  RAYOS is approved to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).  For a full list of RAYOS indications, please see full prescribing information at .

RAYOS is contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients.  Rare instances of anaphylaxis have occurred in patients receiving corticosteroids.

Important information about RAYOS Do not use RAYOS if you are allergic to prednisone.

Long‐term use of RAYOS can affect how your body responds to stress.  Symptoms can include weight gain, severe fatigue, weak muscles, and high blood sugar.

RAYOS can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had.

RAYOS can cause high blood pressure, salt and water retention and low blood potassium.

There is an increased risk of developing holes in the stomach or intestines if you have certain stomach and intestinal disorders.

Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes or severe depression.

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