Navigation Links
Handa Pharmaceuticals Announces Submission of its First-to-File ANDA for AstraZeneca's SEROQUEL(R) XR
Date:7/31/2008

FREMONT, Calif., July 31 /PRNewswire/ -- 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(R) 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(R) 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 http://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(R) and SEROQUEL(R) XR are registered trademarks of the AstraZeneca group of companies.

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


'/>"/>
SOURCE Handa Pharmaceuticals, LLC
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Poniard Pharmaceuticals Reports Second Quarter 2008 Financial Results and Corporate Update
2. Trubion Pharmaceuticals Provides Announcement Dates for Second Quarter and First Six Months Earnings Conference Call
3. DoctorDirectory to Co-market VoSpire ER(R) with DAVA Pharmaceuticals, Inc.
4. Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From FDA for Iloperidone
5. Sagent Pharmaceuticals Launches Amiodarone HCl Injection, USP
6. New Natural Product from Zurich Pharmaceuticals Downs Appetite
7. AUDIO from Medialink and Duramed Pharmaceuticals: Not Your Mothers Menopause
8. Genesis Pharmaceuticals Announces New Board Member and Forms Committees
9. Sound Pharmaceuticals Receives Additional DoD Funding for Its Hearing Regeneration Product
10. AUDIO from Medialink and Duramed Pharmaceuticals: Relief for Women Experiencing Surgical Menopause
11. Genesis Pharmaceuticals Announces SFDA Approval for Radix Isatidis Dispersible Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... ... December 08, 2016 , ... After enjoying ... opened registration today for its 33rd Annual Issues & Research Conference, March ... The theme of the conference is “Persistent Challenges and New Opportunities: Using Research ...
(Date:12/8/2016)... ... December 08, 2016 , ... CURE Media Group, the nation’s ... groups, has aligned with Upstage Lung Cancer in efforts to combat lung cancer, announced ... J. Hennessy, Jr said, “CURE Media Group is honored to team up with Upstage ...
(Date:12/8/2016)... ... December 08, 2016 , ... Launching of ... Unified Instance Manager architecture, meeting the needs of multichannel growth and doubling ... unattended auto-dialing system without agents, Presence Robodialer, provides greater operational capacity, administrative ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... surgery as possible. With this in mind, SIGVARIS has created a new line ... clot) during bed rest and provide the benefits of graduated compression when transitioning ...
(Date:12/8/2016)... ... 08, 2016 , ... The Dan Carlisle Agency, an Alabama-owned ... is announcing the launch of a charity drive to raise support and awareness ... and children in Birmingham has grown steadily since the 1980’s, and the Pathways ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... -- IRIDEX Corporation (NASDAQ: IRIX ) today announced ... stock, $0.01 par value (the "Offering" with such shares being ... terms of the Offering will depend on market and other ... no assurance as to whether or when the Offering may ... proceeds it will receive from this offering for working capital ...
(Date:12/8/2016)... 8, 2016 Global Interventional Radiology Market: ... global interventional radiology market analyzes the current and ... an elaborate executive summary, including a market snapshot ... sub-segments. The research is a combination of ... bulk of our research efforts along with information ...
(Date:12/8/2016)... -- Eli Lilly and Company (NYSE: LLY ) ... trial at the 9 th Clinical Trials on ... not meet the primary endpoint in the EXPEDITION3 clinical ... mild dementia due to Alzheimer,s disease (AD), and Lilly ... treatment of mild dementia due to AD. ...
Breaking Medicine Technology: