SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine F... ( BELLEVUE Wash. Aug. 6 /- SCOLR Ph...)

SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine Formulation

Date:8/6/2008

BELLEVUE, Wash., Aug. 6 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD) announced today that it has submitted to the Food and Drug Administration an Abbreviated New Drug Application (ANDA) for a 120 milligram 12-hour pseudoephedrine tablet based on the Company's patented Controlled Delivery Technology (CDT(R)) platform. This is the first application submitted by SCOLR based on its CDT platform.

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

Stephen J. Turner, SCOLR's Vice President and Chief Technical Officer, stated, "We believe the primary advantages our formulation may have over currently marketed pseudoephedrine tablets relates to the overall efficiency of the formulation. We were able to demonstrate bio-equivalence for our product while significantly reducing the overall tablet size, gaining important manufacturing margin advantages over currently available tablets.

"Since pseudoephedrine tablets now face marketing pressure because of required placement behind the counter in the pharmacy, we believe that margin and size may play an important role in the selection process for consumers, and could give SCOLR an advantage in the competitive store-brands and private label marketplace."

"The ANDA for pseudoephedrine is a major accomplishment for SCOLR," said Daniel O. Wilds, the Company's Chief Executive Officer. "Approval of this product would further substantiate some of the unique advantages of our drug delivery technology and can be an important revenu
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SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine F...( BELLEVUE Wash. Aug. 6 /- SCOLR Ph...),Health