SPRING VALLEY, N.Y., Feb. 24 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX - News) today announced that the U.S. District Court for the District of Maryland last night granted GlaxoSmithKline (GSK) its motion for a temporary restraining order (TRO) 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 (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. 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. In 2005, Par received approval for and introduced Megace® 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 http://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, Inc.
