Medindia
Medindia LOGIN REGISTER
Advertisement

Handa Pharmaceuticals Announces Submission of its First-to-File ANDA for AstraZeneca's SEROQUEL(R) XR

Friday, August 1, 2008 General News
Advertisement
FREMONT, Calif., July 31 Handa Pharmaceuticals, LLC("Handa"), a specialty pharmaceutical company based in Fremont, California,today confirmed that its Abbreviated New Drug Application ("ANDA") forQuetiapine Fumarate Extended-Release Tablets, the generic version ofAstraZeneca's SEROQUEL(R) XR, has been accepted for filing by the U.S. Foodand Drug Administration ("FDA"). Based upon available information, Handabelieves that it is the first applicant to file an ANDA for SEROQUEL(R) XRcontaining a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by the FDA, Handa believes that itsproduct will be entitled to 180 days of generic market exclusivity.
Advertisement

About Handa Pharmaceuticals, LLC

Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that wasestablished in the San Francisco Bay area in November 2005. Handa's executiveleadership has a proven track record of developing controlled-releaseprescription pharmaceutical products that are difficult to formulate. For moreinformation, please visit http://www.handapharma.com.
Advertisement

Forward-Looking Statements

Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectHanda's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Handa disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Handa's current expectations depending upona number of factors affecting Handa's business. These factors include, amongothers, patents and other intellectual property rights held by competitors andother third parties and the uncertainty of the outcome of litigation relatedto such patents and intellectual property rights; the difficulty of predictingthe timing or outcome of product development efforts and FDA or otherregulatory agency approvals or actions; the impact of competitive products andpricing; market acceptance of and demand for Handa's products; difficulties ordelays in manufacturing; and other risks and uncertainties.

SEROQUEL(R) and SEROQUEL(R) XR are registered trademarks of theAstraZeneca group of companies.

Contact: Stephen Cary of Handa Pharmaceuticals, LLC, +1-510-354-2888

SOURCE Handa Pharmaceuticals, LLC
Sponsored Post and Backlink Submission


Latest Press Release on General News

This site uses cookies to deliver our services.By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use  Ok, Got it. Close