New Drugs Approved In July

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The FDA approved Xembify (20% immune globulin subcutaneous) developed by Grifols on July 3, 2019 for the treatment of primary immunodeficiencies.

Primary immunodeficiencies are mostly genetic disorders in which part of the body's immune system is missing or does not function normally causing recurring infections.

Immunoglobulins are mainly used to treat primary and secondary immunodeficiencies, as well as rare neurological conditions, such as chronic inflammatory demyelinating polyneuropathy (CIDP).

The company plans to launch Xembify in the United States in the last quarter of 2019 and is working with healthcare authorities to obtain approval in Canada, Europe and other markets.