Sandoz US News


FDA approves Sandoz Erelzi™ to treat multiple inflammatory diseases

• Erelzi is the first biosimilar etanercept approved by the FDA, offering expanded access to this important medicine • Erelzi is approved for all indications included in the reference product’s label • Erelzi is the second biosimilar from Sandoz to receive FDA approval in the US, building upon established global leadership in biosimilars

Sandoz launches generic version of Crestor®

Princeton, New Jersey, July 21, 2016– Sandoz today announced the U.S. market introduction of rosuvastatin calcium tablets, a generic version of Crestor® by AstraZeneca Pharmaceuticals LP 1.

Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases

Holzkirchen, 13 July, 2016. Sandoz, a Novartis division and leader in biosimilars, announced today that the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference product, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic psoriasis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA).

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