December 13, 2010
Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today announced that the U.S. Food and Drug Administration (“FDA”) has granted tentative approval of the Company’s Abbreviated New Drug Application (“ANDA”) for Quetiapine Fumarate Extended-Release Tablets, 50 mg., 150 mg., 200 mg., 300 mg., and 400 mg., a generic version of AstraZeneca’s SEROQUEL XR®. Based upon available information, Handa believes that it is the first applicant to file an ANDA for SEROQUEL XR® 50 mg., 150 mg., 200 mg., and 300 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Upon receiving final approval by the FDA, Handa believes that the 50 mg., 150 mg., 200 mg., and 300 mg. strengths of its product will be entitled to 180 days of marketing exclusivity.
“Receiving tentative approval of our Quetiapine XR ANDA represents a significant milestone for the product and for Handa Pharmaceuticals as a company,” said Bill Liu, Handa’s President and CEO. “We are executing our plan to build a robust pipeline of controlled release products for global markets.”
According to IMS Health, annual sales of SEROQUEL XR® in the U.S. were about $754 million for the twelve months ended September 30, 2010.
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
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