) announced that it will update intravenous Zofran's (ondansetron)
label to exclude the 32 mg single dose for the prevention of
chemotherapy-induced nausea and vomiting. Intravenous Zofran will
continue to be available at a lower dose of 0.15 mg/kg, three doses
administered at a gap of four hours. As per the changed label, no
single dose of intravenous Zofran should exceed 16 mg.
Zofran's label change was announced after the US Food and Drug
Administration (FDA) issued a Drug Safety Communication disclosing
preliminary results from a Zofran study. It was found that the use
of the 32 mg dose of Zofran or generic versions of the drug can
cause prolongation of QT interval. We note that prolongation
of QT interval can even lead to Torsades de Pointes, a fatal heart
Since a lower dose of intravenous Zofran is recommended for
preventing post-surgical nausea and vomiting, Zofran's use in this
indication remains unaffected by the exclusion of higher dose.
Once the final results from the study are available, Glaxo will
work with the FDA towards developing a safe and effective single
intravenous dose regime.
We currently have a Neutral recommendation on Glaxo. The stock
carries a Zacks #3 Rank (Hold rating) in the short run. A major
part of Glaxo's revenues will be exposed to generic competition as
multiple drugs are scheduled to lose exclusivity in the next few
We expect the company's top line as well as gross margins to remain
under pressure in the coming quarters. In addition to generic
competition, EU pricing pressure will continue to affect sales.
GLAXOSMITHKLINE (GSK): Free Stock Analysis
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