Navigation Links
FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT(R) 12-Hour Pseudoephedrine
Date:1/20/2009

BOTHELL, Wash., Jan. 20 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD) today announced that the U. S. Food and Drug Administration (FDA) has issued a Complete Response letter for its Abbreviated New Drug Application (ANDA) for pseudoephedrine. The application, filed by SCOLR on August 5, 2008, seeks approval to market a 120 mg 12 hour pseudoephedrine tablet based on its patented Controlled Delivery Technology (CDT(R)) platform.

The Complete Response letter requests additional information, all of which was identified by the FDA as "minor." The Company said that it believes it can provide the information to the FDA expeditiously. None of the issues cited by the FDA involve the safety or efficacy of the product.

Tanya Raco, the Company's Associate Vice President of Regulatory Affairs and Quality Assurance, said, "We are pleased that the FDA has moved so quickly to review our application. If approved, this would be SCOLR's first successful product application, but more importantly it would provide additional validation for our underlying technology. We will continue to work closely with the FDA to address the questions raised and advance our CDT(R) 12-hour pseudoephedrine toward approval."

SCOLR is currently in discussions with potential partners for an alliance for this product, but is still open to talk with other companies about this opportunity

About Pseudoephedrine

Pseudoephedrine is a decongestant that is an active ingredient in Sudafed(R) PSE, Allegra(R) D, Claritin(R) D, Zyrtec(R) D and other over-the-counter (OTC) and prescription products. The domestic OTC market for pseudoephedrine-containing products is estimated to exceed $1 billion annually.

About SCOLR Pharma:

Based in Bothell, Washington, SCOLR Pharma, Inc. is a specia
'/>"/>

SOURCE SCOLR Pharma, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Pharmos Issues Letter to Shareholders
2. MichBio Issues 2007/8 Michigan Life Sciences Directory and Resources Guide
3. HHS Issues First Department-Wide Report on Personalized Health Care
4. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
5. Symmetry Medical Discloses Accounting Issues at Sheffield, UK Operating Unit and Possible Restatement
6. CCPM Issues Statement on FDAs GIVE Initiative
7. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
8. FDA Issues Approvable Letter for LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
9. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
10. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
11. Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early Communication
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... Texas (PRWEB) , ... August 28, 2015 , ... ... Riordan, PhD and orthopedic surgeon, Wade McKenna, DO, announced today that the use ... Dallas, Texas, resulted in complete healing of an otherwise non-healing surgical knee wound. ...
(Date:8/27/2015)... CA (PRWEB) , ... August 27, 2015 , ... ... unique opportunity for venture capital funds, investment firms and animal health companies to ... Forum have raised $160 million. Several have also received licensing agreements or distribution ...
(Date:8/27/2015)... 27, 2015  Neogen Corporation (NASDAQ: NEOG ) ... United Kingdom -based Lab M Holdings, ... and diagnostic systems. Lab M was ... provider of microbial testing and diagnostic products for the ... company currently sells into more than 70 countries worldwide, ...
(Date:8/27/2015)... Aug. 27, 2015 The National Necrotizing ... eyes—and life—were saved by doctors at Vanderbilt University Hospital ... NNFF, NovaBay Pharmaceuticals and Dr. John Crew , ... at Seton Medical Center in Daly City, ... a breakthrough approach, pioneered by Dr. Crew, that had ...
Breaking Biology Technology:Dallas-Fort Worth Stem Cell Researchers Use Amniotic Tissue To Successfully Treat Non-Healing Surgical Wound 2Dallas-Fort Worth Stem Cell Researchers Use Amniotic Tissue To Successfully Treat Non-Healing Surgical Wound 3Dallas-Fort Worth Stem Cell Researchers Use Amniotic Tissue To Successfully Treat Non-Healing Surgical Wound 4VetStem Biopharma, Inc. Among Seventeen Companies Selected to Present at the KC Animal Health Investment Forum on September 1st 2015 2VetStem Biopharma, Inc. Among Seventeen Companies Selected to Present at the KC Animal Health Investment Forum on September 1st 2015 3Neogen acquires U.K.-based Lab M Holdings 2Patient's Life and Eyes Saved from Gruesome Flesh-Eating Infection Consuming Her Face 2Patient's Life and Eyes Saved from Gruesome Flesh-Eating Infection Consuming Her Face 3
... Sept. 5 Vical Incorporated,(Nasdaq: VICL ) ... Global Life,Sciences Conference will be webcast live on ... Vical,s President and Chief Executive Officer,Vijay B. Samant, ... programs, and strategic partnerships. The webcast will be,available ...
... 4, ev3 Inc. (Nasdaq: EVVV ) and FoxHollow,Technologies, ... has set,October 4, 2007 as the date of the ... merger with ev3. The record date for,determining stockholders entitled ... business on August 30, 2007. FoxHollow and ev3 anticipate ...
... HOUSTON, Sept. 4, 2007 Computing researchers at ... Nanyang Technological University (NTU) today announced the formation ... The joint research initiative, valued at 4 million ... production costs for embedded microchips -- special-purpose computer ...
Cached Biology Technology:Vical to Present at Upcoming Investor Conferences 2ev3 and FoxHollow Announce Date for Special Meeting of FoxHollow Stockholders to Vote on Proposed Merger 2ev3 and FoxHollow Announce Date for Special Meeting of FoxHollow Stockholders to Vote on Proposed Merger 3ev3 and FoxHollow Announce Date for Special Meeting of FoxHollow Stockholders to Vote on Proposed Merger 4ev3 and FoxHollow Announce Date for Special Meeting of FoxHollow Stockholders to Vote on Proposed Merger 5Rice, Nanyang Tech collaborate on sustainable nanoelectronics 2Rice, Nanyang Tech collaborate on sustainable nanoelectronics 3
(Date:8/20/2015)... Calif. , Aug. 20, 2015   ... focused on improving the user experience and security ... vision technologies, today announced that its TrulySecure™ ... biometric authentication software to be FIDO Certified™. ... TrulySecure for compliance with the FIDO UAF (Universal ...
(Date:8/17/2015)... , Aug. 17, 2015  NXT-ID, Inc. (NASDAQ: ... company focused on the growing mobile commerce market and ... sales campaign for Q4 2015. The new marketing campaign ... consisting of Amplitude Marketing Group ( http://amplitudemarketing.com/ ) and ... is a leader in retail driven marketing and brand ...
(Date:8/11/2015)... August 11, 2015 Today, ZUK announced its ... as well as expected revenues in 2015 that relate to sales ... revenue guidance of approximately 2,200 MSEK for 2015. Jörgen ... prominent smartphone manufacturer in China ... selected FPC1 155 for Z1 ...
Breaking Biology News(10 mins):TrulySecure From Sensory Becomes First Face and Voice Biometrics Technology to be FIDO UAF Certified 2TrulySecure From Sensory Becomes First Face and Voice Biometrics Technology to be FIDO UAF Certified 3TrulySecure From Sensory Becomes First Face and Voice Biometrics Technology to be FIDO UAF Certified 4TrulySecure From Sensory Becomes First Face and Voice Biometrics Technology to be FIDO UAF Certified 5NXT-ID, Inc. Launches Sales Campaign for Wocket Smart Wallet with Award Winning Marketing Team 2NXT-ID, Inc. Launches Sales Campaign for Wocket Smart Wallet with Award Winning Marketing Team 3FPC's Touch Fingerprint Sensor FPC1155 in ZUK's Smartphone Z1 2
... The battle against obesity in this country could be ... newly published study in the Journal of Physical Activity ... Denver demonstrated the effectiveness of changing behaviors at a ... viable option to address the nations obesity epidemic. ...
... The vision system used to process color is separate ... new study by researchers at New York Universitys Center ... and Neurobiology at Germanys University of Wrzburg. The findings, ... of the National Academy of Sciences, run counter to ...
... to ravage Australias native landscapes, rabbit fish may help save ... The reason, say scientists, is the same in both cases ... of stripping an area of vegetation. However, in the case ... problem and the rabbit fish, the answer. When ...
Cached Biology News:Community-intervention study links successful town makeover focused on boosting calcium and exercise 2Scientists find color vision system independent of motion detection 2Rabbits to the rescue of the reef 2Rabbits to the rescue of the reef 3
... a hairpin primer labeled with a ... non-fluorescent quencher) and a 3 single-stranded ... identical to the UniPrimer provided in ... and is provided at a concentration ...
Rabbit polyclonal to MCP2 ( Abpromise for all tested applications). entrezGeneID: 6355 SwissProtID: P49873...
...
... and high speed homogeneous assay for the ... for screening of inhibitors in a high-throughput ... on a fluorescence superquenching technology that does ... universal platform provides flexibility for assaying any ...
Biology Products: