News March
Glaxo Loses U.S. Court Bid To Stop Generic Flonase
07th March 2006
GlaxoSmithKline Plc has lost its legal attempt to prevent the
launch of generic versions of its allergy nasal spray, Flonase,
in the United States, Europe's biggest drug maker said on Tuesday.
Glaxo had lodged the appeal after privately held Boehringer Ingelheim
subsidiary Roxane Laboratories secured Food and Drug Administration
approval for its generic version of the product last month. It argued
the FDA had not issued proper guidelines for nasal spray generics.
Flonase recorded sales of 506 million pounds in the United States
last year, representing 2.3 percent of Glaxo's total revenues.
A generic form of the medicine had been widely expected by analysts
but the approval of the Roxane formulation came earlier than many
had anticipated.
A Glaxo spokesman reiterated on Tuesday that financial guidance
for 2006 would not change as a result of the early generic launch.
Glaxo is predicting earnings per share will increase this year by
around 10 percent.
Glaxo has agreed with Par Pharmaceutical Cos Inc that it can launch
an authorised generic version of Flonase in the United States once
Roxane's spray reaches the market.
Source
http://business.scotsman.com/latest.cfm?id=346102006
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