Glaxo Smith Kline Hit Hard by FDA Ruling

November 21 14:24 2005 Print This Article

LONDON, November 21 – British pharmaceutical giant Glaxo Smith Kline has been hit hard by a new ruling of the American Food and Drug Administration (FDA). The FDA has imposed tough restrictions on the use of Glaxo Smith Kline’s leading drug, Advair. This drug is one of the best treatments for asthma and very much used by patients all over the world. This drug is known as Seretide in the United Kingdom.

The new regulation means that Advair will only be prescribed when all other treatments have failed to succeed. This also includes new labeling of the drug because of possible, not yet entirely proven, side effects. Considering that Advair is the best-selling drug for Glaxo Smith Kline means that this could have serious effects on their revenue and profits for the coming year. Needless to say the shares dropped immediately. Advair was responsible for $2.8 billion in sales in America alone last year, worldwide this added up to a staggering $4.5 billion in sales.

Glaxo immediately responded with a statement claiming that this new regulation could lead to serious health issues for asthma patients. Keeping the best treatment till last is no solution, they added. They also pointed out a very valid point, in July of this year an FDA advisory committee issued a report in favor of Advair and since that advise no new studies have come out, so how come the FDA changed their minds all of the sudden?

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