FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT(R) 12-Hour Pseudoephedrine
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
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.
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