Healthcare Industry News: allergic rhinitis
News Release - March 7, 2006
Par Pharmaceutical Resumes Shipment Of Generic Flonase(R)SPRING VALLEY, N.Y., March 7 (HSMN NewsFeed) -- Par Pharmaceutical Companies, Inc. (NYSE: PRX ) today announced that it has resumed shipment of fluticasone propionate nasal spray, 50mcg., which is fully substitutable for GlaxoSmithKline's (GSK) Flonase. On February 23, Par halted all shipments in compliance with a temporary restraining order (TRO) granted to GSK by the U.S. District Court for the District of Maryland. Last evening, the court denied GSK's motion for a preliminary injunction to set aside the U.S. Food and Drug Administration's (FDA) final decision approving an abbreviated new drug application (ANDA) for a generic version of Flonase. The court also lifted the suspension of the FDA's approval of an ANDA for a generic version of Flonase and the TRO was permitted to expire. This decision permits the marketing and sale of generic versions of Flonase to resume. Flonase is a synthetic corticosteroid anti-inflammatory agent indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Annual U.S. sales of Flonase exceed $900 million.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced MegaceŽ ES, its first branded pharmaceutical product, and expects to launch its second in 2006. Par's Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 100 generic drugs. For press release and other company information, visit www.parpharm.com.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
Source: Par Pharmaceutical Companies
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