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HyQ FDA Approval Status

FDA Approved: No
Brand name: HyQ
Generic name: immune globulin and recombinant human hyaluronidase
Company: Baxter International Inc.
Treatment for: Primary Immunodeficiency Syndrome

HyQ (immune globulin and recombinant human hyaluronidase) is an investigational combination immunoglobulin product intended for the treatment of patients with primary immunodeficiencies.

In August 2012, Baxter International Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for HyQ had not been approved.

Development timeline for HyQ

Aug 20, 2012Halozyme Confirms Baxter Has Received A Complete Response Letter For HyQ BLA
Aug  2, 2012Baxter Confirms Receipt of Complete Response Letter on HyQ

Further information

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