Tag Archives: sandoz

November, 2018

September, 2018

  • 28 September

    FDA Approves Pediatric Dose of Sandoz’s Symjepi Injection

    PRINCETON, N.J., Sept. 27, 2018 /PRNewswire/ — Sandoz Inc. today announced that the US Food and Drug Administration has approved SYMJEPI™ (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children. Sandoz will distribute and commercialize SYMJEPI™ (epinephrine) 0.15 mg Injection, as well as SYMJEPI 0.3 mg …

June, 2018

May, 2018

January, 2018

December, 2017

September, 2017

March, 2017

December, 2016

  • 5 December

    Sandoz Announces New Data on Proposed Biosimilar Rituximab

    Holzkirchen, December 5, 2016 – Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced data from the ASSIST-FL trial. The confirmatory safety and efficacy study shows GP2013 met its primary endpoint of overall response rate (ORR), demonstrating equivalence with the reference product, MabThera®*, in 629 …

August, 2016

  • 31 August

    FDA Approves Sandoz’s Erelzi, a Biosimilar to Enbrel

    Holzkirchen, August 30, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) approved Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) …