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Pharma & Bio Ingredients
Late Thursday, the U.S. District Court for the District of Maryland granted Glaxo's motion to set aside the FDA decision on generic forms of Flonase.
UK-based Glaxo, Europe's biggest pharmaceutical company, argues that the FDA failed to set up a method to make a copied version of Flonase. It claims the FDA applied one set of quality standards to Flonase and another to the generic form, Glaxo spokeswoman Mary Anne Rhyne said.
The FDA earlier this week said the only distinction between the generic and the branded drug is the price. Drugs become available in generic form, typically at a fraction of their original price, when patent protection comes out.
The generic approval came earlier than Glaxo had expected, as many analysts had not factored in approval until 2007. Regulators and drugmakers often argue about the timing of available generics, in disputes over patent expiration and product equivalence issues.
