Wonder if this will help it today - Yesterday may have been the hard shake of weak longs for the major run..... I am not sure what the profit factor or demand for this product would be
Taro Receives FDA Approval for Alclometasone Dipropionate Ointment USP, 0.05% ANDA; Generic Equivalent to Aclovate Ointment
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Fri Jul 30 07:00:00 2004 EST
HAWTHORNE, N.Y., Jul 30, 2004 (BUSINESS WIRE) --
Taro
Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today that its
U.S. affiliate has received approval from the U.S. Food and Drug
Administration ("FDA") for its Abbreviated New Drug Application
("ANDA") for Alclometasone Dipropionate Ointment, USP 0.05%
("alclometasone ointment").
Taro's alclometasone ointment is bioequivalent to
GlaxoSmithKline's Aclovate(R) ointment, a low to medium potency
topical corticosteroid product. Alclometasone ointment, a prescription
product, is used for the treatment of inflammatory skin diseases. U.S.
sales of Aclovate(R) ointment were approximately $2.5 million in 2003,
according to industry sources.
Taro, a leader in topical dermatological products, manufactures
and markets a wide range of prescription and over-the-counter creams,
ointments and gels.
Currently, Taro has 29 filings at the FDA: 28 ANDAs, including one
tentative approval, plus a New Drug Application related to the
Company's proprietary NonSpil(TM) liquid drug delivery system. In
addition, the Company has regulatory filings in Canada, Israel and
other countries.
Taro is a multinational, science-based pharmaceutical company,
dedicated to meeting the needs of its customers through the discovery,
development, manufacturing and marketing of the highest quality
healthcare products.
For further information on Taro Pharmaceutical Industries Ltd.,
please visit the Company's website at www.taro.com.
Certain statements in this release are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding the Company's alclometasone
ointment and other dermatology products. Although Taro Pharmaceutical
Industries Ltd. believes the expectations reflected in such
forward-looking statements to be based on reasonable assumptions, it
can give no assurance that its expectations will be attained. Factors
that could cause actual results to differ include industry and market
conditions; slower than anticipated penetration of new markets;
physician, pharmacist or patient acceptance of Taro's alclometasone
ointment and other dermatology products; changes in the Company's
financial position; regulatory actions; and, other risks detailed from
time to time in the Company's SEC reports, including its 2003 Annual
Report on Form 20-F. Forward-looking statements speak only as of the
date on which they are made. The Company undertakes no obligation to
update, change or revise any forward-looking statements, whether as a
result of new information, additional or subsequent developments or
otherwise.
SOURCE: Taro Pharmaceutical Industries Ltd.
Taro Pharmaceutical Industries Ltd., Hawthorne
Daniel Saks, 914-345-9000 ext. 6208
or
Kevin Connelly, 914-345-9000 ext. 6338
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