Par Pharmaceutical resumes shipment of generic Flonase

By Elaine Rigoli

Tampa, Fla., March 7 - Par Pharmaceutical Cos. Inc. announced Tuesday that it has resumed shipment of fluticasone propionate nasal spray, 50 mcg, which is fully substitutable for GlaxoSmithKline's Flonase.

On Feb. 23, Par halted all shipments in compliance with a temporary restraining order granted to GlaxoSmithKline by the U.S. District Court for the District of Maryland.

The court denied GlaxoSmithKline's motion for a preliminary injunction to set aside the Food and Drug Administration's final decision approving an abbreviated New Drug Application for a generic version of Flonase, according to a company news release.

The court also lifted the suspension of the FDA's approval of an aNDA for a generic version of Flonase and the restraining order was permitted to expire. This decision permits the marketing and sale of generic versions of Flonase to resume, the release said.

Flonase is a synthetic corticosteroid anti-inflammatory agent indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis.

Annual U.S. sales of Flonase exceed $900 million, the release said.

Par Pharmaceutical, based in Spring Valley, N.Y., develops, manufactures and markets generic drugs and branded pharmaceuticals for specialty markets.

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