HAWTHORNE, N.Y., Mar 23, 2006 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. ("Taro," NASDAQ:
TARO) reported today that its U.S. affiliate has received tentative
approval from the U.S. Food and Drug Administration ("FDA") for its
Abbreviated New Drug Application ("ANDA") for Terbinafine
Hydrochloride Cream 1% ("terbinafine cream").
The FDA has determined that Taro's terbinafine cream is safe and
effective for use when compared with the reference listed drug
product, Lamisil(R) Cream of Novartis Consumer Health Inc. Terbinafine
cream is an over-the-counter antifungal product which cures most
athlete's foot, jock itch and ringworm, and relieves the itching,
cracking, burning and scaling which accompany these conditions.
According to industry sources, Lamisil(R) Cream has annual U.S. sales
in excess of $45 million.
The tentative ANDA approval for terbinafine cream, which Taro
believes is the first received by a company in the U.S., is an FDA
determination that Taro's ANDA submission for this product currently
satisfies the substantive requirements for approval, subject to the
expiration of all relevant patents or statutorily imposed
exclusivities, restrictions and any new information that may come to
the FDA's attention. Tentative approvals do not grant marketing
rights; a company may only market a product upon receiving final
approval for an ANDA submission. The listed patent on Lamisil(R) Cream
expires on December 30, 2006.
Taro Pharmaceutical Industries Ltd. 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 terbinafine cream
product. 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
consumer acceptance of the new Taro 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 Annual
Reports 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.
Daniel Saks, 914-345-9000 ext. 6208
or
Kevin Connelly, 914-345-9000 ext. 6338