Handa Pharmaceuticals Announces Submission of its First-to-File ANDA for AstraZeneca’s SEROQUEL® XR
July 31, 2008
Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based
in Fremont, California, today confirmed that its Abbreviated New Drug
Application (“ANDA”) for Quetiapine Fumarate Extended-Release Tablets, the
generic version of AstraZeneca’s SEROQUEL® XR, has been accepted for filing by
the U.S. Food and Drug Administration (“FDA”). Based upon available information,
Handa believes that it is the first applicant to file an ANDA for SEROQUEL® XR
containing a Paragraph IV certification, under the provisions of the
Hatch-Waxman Act. Should its ANDA be approved by the FDA, Handa believes that
its product will be entitled to 180 days of generic market exclusivity.
About Handa Pharmaceuticals, LLC
Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was
established in the San Francisco Bay area in November 2005. Handa’s executive
leadership has a proven track record of developing controlled-release
prescription pharmaceutical products that are difficult to formulate. For more
information, please visit
www.handapharma.com.
Forward-Looking Statements
Any statements contained in this press release that refer to future events or
other non-historical facts are forward-looking statements that reflect Handa's
current perspective of existing trends and information as of the date of this
release. Except as expressly required by law, Handa disclaims any intent or
obligation to update these forward-looking statements. Actual results may differ
materially from Handa’s current expectations depending upon a number of factors
affecting Handa's business. These factors include, among others, patents and
other intellectual property rights held by competitors and other third parties
and the uncertainty of the outcome of litigation related to such patents and
intellectual property rights; the difficulty of predicting the timing or outcome
of product development efforts and FDA or other regulatory agency approvals or
actions; the impact of competitive products and pricing; market acceptance of
and demand for Handa's products; difficulties or delays in manufacturing; and
other risks and uncertainties.
SEROQUEL® and SEROQUEL® XR are registered trademarks of the AstraZeneca group of
companies.
Source: Handa Pharmaceuticals, LLC
Contact: Stephen Cary of Handa Pharmaceuticals, LLC, +1-510-354-2888

Handa Pharmaceuticals, LLC
39465 Paseo Padre Parkway Suite 2600
Fremont, California 94538
United States
Phone: (510) 354-2888
Fax: (510) 354-2887
info@handapharma.com



