GlaxoSmithKline receives FDA approval for influenza vaccine

GlaxoSmithKline has announced it has received a Complete Response letter from the US Food and Drug Administration (FDA) for its Q-Pan H5N1 Pandemic Influenza medication.

The pharmaceutical company confirmed the correspondence was in response to the Biologics License Application for its Pandemic Influenza A Virus Monovalent Adjuvanted candidate vaccine.

Using the compound, medical professionals intend to provide active immunisation for the prevention of disease in adults over 18 years of age and older who are at increased risk of being exposed to the H5N1 influenza virus subtype.

The FDA usually issues a Complete Response letter when a Prescription Drug User Fee Act date draws closer, yet additional review time is necessary prior to the drug's approval.

GlaxoSmithKline is currently working alongside the US body to complete the scientific review in a timely manner.

The pharmaceutical organisation's H5N1 influenza vaccine programme has been supported by a development contract with the Biomedical Advanced Development and Research Authority of the US Department of Health and Human Sciences.