SOUTH PLAINFIELD, N.J., April 27 /PRNewswire-FirstCall/ -- ABLE LABORATORIES, INC. , today announced that it has received Food and Drug Administration approval for its Abbreviated New Drug Application (ANDA) for Theophylline Extended-Release Tablets, 600mg, which are therapeutically equivalent to Uniphyl(R) Tablets, 600mg of The Purdue Frederick Company. The total brand sales for Able's newly approved drug (used in treatment of air flow obstructions associated with chronic asthma and other chronic lung diseases including emphysema and bronchitis) is estimated to be approximately $12 million according to recent market data.
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Able is the first company to receive an ANDA approval for the generic equivalent of Uniphyl(R) Tablets, 600mg.
Able Laboratories is a developer and manufacturer of generic pharmaceuticals. Further information on Able may be found on the Company's web site, http://www.ablelabs.com/.
Except for historical facts, the statements in this news release, as well as oral statements or other written statements made or to be made by Able Laboratories, Inc., are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. For example, statements about the Company's ability to formulate drug products, its operations and ability to increase sales and manage its growth, the expected effects of the Company's expansion of its production facilities, the current or expected market size for the Company's products, the adequacy of the Company's manufacturing capacity, the availability of sufficient capital, the success of current or future product offerings, research and development efforts and the Company's ability to file for and obtain U.S. Food and Drug Administration approvals for future products, are forward-looking statements. Forward-looking statements are merely the Company's current predictions of future events. The statements are inherently uncertain, and actual results could differ materially from the statements made herein. There is no assurance that the Company will continue to achieve the sales levels necessary to make its operations profitable or that its ANDA filings and approvals will be completed and obtained as anticipated. For a description of additional risks, and uncertainties, please refer to the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2003. The Company assumes no obligation to update its forward-looking statements to reflect new information and developments.
Company Contacts: Investor Contact:
Able Laboratories, Inc. Investor Relations
Jay Wadekar, President & CEO (908) 754-2253 ext. 664
Robert Weinstein, Vice President & CFO Email: IR@ablelabs.com
(908) 754-2253
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http://www.newscom.com/cgi-bin/prnh/20030721/ABLELOGOAble Laboratories, Inc.
CONTACT: Jay Wadekar, President & CEO, Robert Weinstein, Vice President& CFO, +1-908-754-2253, or Investor Relations - +1-908-754-2253, ext. 664,IR@ablelabs.com, all of Able Laboratories, Inc.