Navigation Links
Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
Date:8/19/2007

WOODCLIFF LAKE, N.J., Aug. 15 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patent listed by Warner Chilcott (US), Inc. in connection with Warner Chilcott's Femcon(R) FE (norethindrone and ethinyl estradiol) chewable oral contraceptive. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Femcon FE.

Barr filed its ANDA containing a paragraph IV certification for a generic Femcon FE product with the U.S. Food & Drug Administration (FDA) in April 2007, and received notification of the application's acceptance for filing in August 2007. Following receipt of the notice from the FDA, Barr notified Warner Chilcott, the New Drug Application (NDA) holder and patent owner.

On August 15, 2007, Warner Chilcott announced it had received a Paragraph IV certification notice for a generic version of its Femcon FE oral contraceptive from Barr Laboratories, Inc. Warner Chilcott indicated that it is evaluating the paragraph IV certification notice.

Femcon FE is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraceptive. The product had sales of approximately $16 million since it was launched in the U.S. in December 2006, based on IMS sales data ending June 2007.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 115 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment in the markets where we operate; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (such as PLIVA d.d.) and products we acquire and implementing our new SAP enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through our PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our significantly increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed in our SEC filings, including in our Transition Report on Form 10-K/T for the six months ended December 31, 2006.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.


'/>"/>
SOURCE Barr Pharmaceuticals, Inc.

Copyright©2007 PR Newswire.

Related biology technology :

1. Stratagenes Human cDNA Microarrays: Perform Gene Expression Profiling and Discover New Genes
2. The Flexible matriXarray Chip System: A New Perspective for Probe Optimization in Gene-Expression Profiling
3. Ambion Offers Gene Expression Profiling Service
4. Novel MicroRNA Array Technology for Sensitive miRNA Profiling
5. MicroRNA Profiling by Array Analysis Reveals Critical BioMarkers
6. Total RNA from Whole Blood for Expression Profiling
7. Unmask Blood RNA for Gene Expression Profiling
8. Proteomics in Bladder Cancer Research: Protein Profiling of Bladder Squamous Cell Carcinomas, Rev C
9. Microgenomic Expression Profiling
10. Laser Capture Microdissection (LCM) and Expression Profiling of Long-Range Projection Neurons
11. A Novel Process for Gene Expression Profiling of Rat and Mouse Tissues from Formalin-Fixed Paraffin-Embedded Sections Using Microarrays
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/20/2017)... ... September 20, 2017 , ... Proscia ... Pathology , a provider of whole slide imaging solutions, are hosting a pre-conference ... workshop, entitled “Successfully Deploying a Best-in-Class Strategy for Digital Pathology,” will feature Proscia ...
(Date:9/20/2017)... ... September 20, 2017 , ... Foresight Institute, a leading ... transformative technologies, announced the winners for the 2017 Foresight Institute Feynman Prizes.These are ... nanotechnology/molecular manufacturing. , Established in 1993 and named in honor of pioneer physicist ...
(Date:9/19/2017)... ... September 19, 2017 , ... Participants of this ... high-performance fume hood. Along with the advantages and disadvantages of ductless, filtered fume ... hoods in the laboratory. , Attendees will learn from an industry expert about ...
(Date:9/19/2017)... ... September 19, 2017 , ... The new and improved Oakton® ... pocket testers even stand upright with a new cap design that is versatile, functional ... the field who need to test water quality. , The Oakton pocket testers have ...
Breaking Biology Technology:
(Date:4/6/2017)... , April 6, 2017 Forecasts ... ANPR, Document Readers, by End-Use (Transportation & Logistics, Government ... Oil, Gas & Fossil Generation Facility, Nuclear Power), Industrial, ... Other) Are you looking for a definitive ... ...
(Date:4/3/2017)... , April 3, 2017  Data captured ... engineering platform, detected a statistically significant association ... prior to treatment and objective response of ... potential to predict whether cancer patients will ... treatment, as well as to improve both pre-infusion ...
(Date:3/28/2017)... March 28, 2017 The report ... (Camera, Monitors, Servers, Storage Devices), Software (Video Analytics, VMS), ... - Global Forecast to 2022", published by MarketsandMarkets, the ... and is projected to reach USD 75.64 Billion by ... 2022. The base year considered for the study is ...
Breaking Biology News(10 mins):