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Dohme get FDA approval

6th February 2006

GlaxoSmithKline (GSK) and Merck have both received US approval for two new treatments.

The US Food and Drug Administration (FDA) gave approval to GlaxoSmithKline Imitrex Injection that allows migraine patients to inject themselves with the Imitrex STATdose System.

Dr Robert Kaniecki, director of the Headache Centre at the University of Pittsburgh, said: “The availability of Imitrex Injection provides a simple and effective treatment option for patients who experience certain types of migraines.

“Migraine patients who experience nausea or vomiting with their headaches often require an injection, since oral treatments are typically not well tolerated by these patients.

“Additionally, injections bypass the digestive system and enter the bloodstream quickly, which is especially important for treating certain migraine attacks, such as morning and rapidly escalating migraines.”

Merck, parent company of Merck Sharp & Dohme, also got FDA approval for Rotateq the only rotavirus gastroenteritis vaccine available in the US.

Dr Paul Offit, chief of infectious diseases at The Children’s Hospital of Philadelphia and co-inventor of the vaccine, said: “Virtually all children will experience rotavirus. While some children experience mild symptoms of rotavirus, infection can be severe and lead to dehydration that can be fatal.

“The FDA approval of this vaccine is exciting for paediatricians because they will now have a way to help protect infants from rotavirus.

“For the many people who have worked on the research and development of this vaccine for nearly 20 years, to see that effort result in the availability of a vaccine to prevent this common and unpredictable disease is something to be proud of.”

track© Adfero Ltd

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