Able Laboratories Receives Three FDA Approvals for Hydroxyzine Hydrochloride Tablets, USP 10mg, 25mg and 50mg
SOUTH PLAINFIELD, N.J., July 23 -- ABLE
LABORATORIES, INC. (Nasdaq: ABRX), today announced that it has received Food
and Drug Administration approval for its Abbreviated New Drug Applications
("ANDAs") for Hydroxyzine Hydrochloride Tablets, USP 10mg, 25mg and 50mg,
which are therapeutically equivalent to Hydroxyzine Hydrochloride Tablets, USP
10mg, 25mg and 50mg of Pliva, Inc. (formerly Sidmak Laboratories, Inc.). The
total sales for Able's newly approved drugs (used in the treatment of both
anxiety and tension associated with psychoneurosis and management of pruritis
due to adverse allergic reactions), is estimated to be approximately $117
million according to recent market data.
Able, for 2004, has received 10 ANDA approvals to-date, five within the
last two months.
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 Quarterly Report on Form 10-Q for the quarter ended March 31,
2004 and 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.
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