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Sandoz announces US FDA approval and launch of Glatopa® 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis

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3.4 from 7 votes
Tuesday, February 13, 2018

Holzkirchen - Sandoz, a Novartis division, announced the US FDA approval and launch of Glatopa (glatiramer acetate injection) 40 mg/mL.

Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable, AP-rated generic version of Copaxone (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. and Sandoz and is produced in the US.

"The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products. We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support services for Glatopa through GlatopaCare," said Richard Francis, CEO, Sandoz.

Glatopa 40 mg/mL is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa 40 mg/mL, along with Glatopa 20 mg/mL, will offer patients a complete range of dosing options. Glatopa 20 mg/mL was made available in the US in June 2015. Patients can expect the same patient services for Glatopa 40 mg/mL as for Glatopa 20 mg/mL.

Sandoz GlatopaCare will offer a $0 co-pay support program to qualified patients. To help increase patient confidence with administering injections, patients will receive personalized injection training, 24-hour access to nurses for Glatopa-related questions and a free Starter Kit, which includes the Glatopaject injection device, designed to work with both Glatopa 20 mg/mL and 40 mg/mL prefilled syringes.

About Sandoz
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 portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

Contacts:
Chris Lewis
Sandoz Global Communications
Phone: +49 8924 476 1906 (direct)
Phone: +49 174 244 9501 (mobile)
Email: chris.lewis@sandoz.com

Source: Sandoz
3.42857142857
3.4 from 7 votes
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