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    WOODCLIFF LAKE, N.J., May 11 /PRNewswire-FirstCall/ -- Barr
 Pharmaceuticals, Inc. (NYSE:   BRL) today announced that its subsidiary, Barr
 Laboratories, Inc., has received tentative approval from the U.S. Food and
 Drug Administration (FDA) for its generic version of Janssen Pharmaceutica
 Products, L.P.'s Razadyne(R) (Galantamine Hydrobromide), 4mg, 8mg and 12mg
 Tablets.
     A tentative approval reflects FDA's preliminary determination that a
 generic product satisfies the substantive requirements for approval,
 subject to the expiration of all statutorily imposed non-approval periods.
 A tentative approval does not allow the applicant to market the generic
 drug product.
     Barr filed an Abbreviated New Drug Application (ANDA) with the U.S.
 Food & Drug Administration (FDA) for Janssen's Razadyne (Galantamine
 Hydrobromide), 4mg, 8mg and 12mg Tablets on February 28, 2005, the first
 day that an ANDA containing a Paragraph IV certification could be submitted
 based on the expiration of the New Chemical Entity (NCE) exclusivity on the
 product. Barr received notification from the FDA of the application's
 acceptance for filing in April 2005. Following receipt of notice from FDA,
 Barr notified Janssen, the New Drug Application (NDA) holder, and
 Synaptech, the patent owner, of Barr's challenge to the patents protecting
 Razadyne.
     In June 2005, Janssen and Synaptech filed suit against Barr
 Laboratories in the District Court of Delaware to formally initiate the
 patent challenge process under the Hatch-Waxman Act. Trial is set for May
 21, 2007. The 30- month stay for the case expires in August 2008.
     Razadyne is indicated for the treatment of mild to moderate dementia of
 the Alzheimer's type. The product had annual sales of approximately $140
 million for the twelve months ending March 2007, according to IMS sales
 data.
     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.

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