The US District Court for the District of Maryland granted GlaxoSmithKline (GSK) its motion for a temporary restraining order (TRO) to set aside the US FDA's final decision approving Par Pharmaceuticals' abbreviated new drug application (ANDA) for a generic version of Glaxo's Flonase (fluticasone propionate) nasal spray.

While the TRO is pending, the approval and any future approval by the FDA of an ANDA allowing the marketing and sale of a generic version of GSK's Flonase nasal spray is and shall be suspended. The TRO will expire on March 6, 2006, states the company release.

Earlier this week, the US FDA approved the first generic form of Flonase, which generates more than $1 billion in sales a year for Glaxo. The FDA approved a version made by privately-held Roxane Laboratories of Ohio, but Glaxo also has struck a deal for Par to sell a Glaxo generic.

Par has halted all shipments of fluticasone propionate nasal spray and will take other steps necessary to comply with this order.

Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.