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 specialty pharmaceutical company. SCOLR Pharma's corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.368.1050 or visit http://www.scolr.com/.

This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements related to the timing and success of our products under development and the potential for alliances. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products and we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.

    Contact:
    Investor Relations:
    Cameron Associates
    Kevin McGrath
    212.245.4577
    Kevin@cameronassoc.com


'/>"/>
SOURCE SCOLR Pharma, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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:3/23/2017)... 23, 2017 Research and Markets has ... report to their offering. ... The Global Market for Bioproducts ... 2016 at a CAGR of 8.9%, This ... bioproducts into seven major product segments: bio-derived chemicals, biofuels, pharmaceuticals ...
(Date:3/23/2017)...  GlobeImmune, Inc. today announced it has entered into ... shares of its common stock to NantCell, Inc., a ... the sale of its common stock, NantCell has agreed ... GlobeImmune 200,000 shares, an estimated $2.0 million in value, ... pleased to enter into this strategic agreement with NantCell," ...
(Date:3/23/2017)... , March 23, 2017 Kineta, ... development of novel therapies in immuno-oncology, today announced ... lead" small molecule compounds that activate interferon response ... pathways and demonstrate immune-mediated tumor regression in a ... the study who demonstrated complete tumor regression to ...
(Date:3/23/2017)... , March 23, 2017  Agriculture technology company Cool ... financing and note conversion to commercialize its Cool Terra ... focused on developing products that are simultaneously profitable as ... in the last 18 months. This latest round of ... Venture Partners. The company,s primary product, ...
Breaking Biology Technology:
(Date:3/23/2017)... The report "Gesture Recognition and Touchless Sensing Market by ... Global Forecast to 2022", published by MarketsandMarkets, the market is expected to be ... 2017 and 2022. Continue Reading ... ... ...
(Date:3/22/2017)... Vigilant Solutions , a vehicle location ... announced today the appointment of retired FBI special agent ... business development. Mr. Sheridan brings more than ... focus on the aviation transportation sector, to his new ... Sheridan served as the Aviation Liaison Agent Coordinator (ALAC) ...
(Date:3/13/2017)... HAMBURG, Germany , March 13, 2017 Future of ... ... DERMALOGs Face Matching enables to match ... characteristics forms the basis to identify individuals. (PRNewsFoto/Dermalog Identification Systems) ... DERMALOG,s "Face Matching" is the fastest software for ...
Breaking Biology News(10 mins):