WOODCLIFF LAKE, N.J., Sept. 10 Par Pharmaceutical Companies, Inc. (NYSE :PRX) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets. Nateglinide is a generic version of Novartis' Starlix(R). Annual U.S. sales of Starlix(R) are approximately $124 million, according to IMS Health data. Par will begin shipping the 60mg and 120mg strengths of nateglinide to the trade immediately.
Important information about nateglinide tablets
Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes mellitus.
Nateglinide tablets are contraindicated in patients with a known hypersensitivity to the drug or its inactive ingredients, Type I diabetes and diabetic ketoacodosis.
About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit www.parpharm.com.
Safe Harbor Statement
Certain statements in this news 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, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in Item 1A of the Company's subsequent Quarterly Reports on Form 10-Q, in other of the Company's filings with the SEC from time to time, including Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Par Pharmaceutical Companies, Inc.