Par Pharmaceutical Receives Final Approval To Market Generic Starlix(R)
September 10 2009 - 12:03PM
PR Newswire (US)
Par to Begin Shipping Nateglinide Immediately WOODCLIFF LAKE, N.J.,
Sept. 10 /PRNewswire-FirstCall/ -- 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 . Annual U.S. sales of Starlix 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 http://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. DATASOURCE: Par Pharmaceutical
Companies, Inc. CONTACT: Allison Wey, Par Pharmaceutical Companies,
Inc., +1-201-802-4000 Web Site: http://www.parpharm.com/
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