FDA declines to approve GSK vaccine

Agency delivers complete response letter regarding MenHibrix

PHILADELPHIA — The Food and Drug Administration has declined to approve a vaccine developed by GlaxoSmithKline, the drug maker said.

GSK said it received a complete response letter from the FDA for MenHibrix (Hib-MenCY-TT), a vaccine for toddlers ages 6 weeks to 15 months against infection by Neisseria meningitides serogroups C and Y and Haemophilus influenza type b, also known as Hib. The FDA issues a complete response letter when it has finished reviewing an approval application for a drug or vaccine, but questions remain that preclude final approval; the company applying can resubmit once it has addressed the FDA's questions.

The London-based company said this was the second complete response letter it had received from the FDA with regard to MenHibrix, though it did not specify which issues the agency had raised.

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