Par Pharmaceutical Companies, Inc. halted all shipments of fluticasone (fluticasone propionate) propionate nasal spray as 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 final decision approving an abbreviated new drug application (ANDA) for a generic version of Flonase 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, stated a release.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace ES, for specialty markets.