SCOLR Pharma, Inc. (DDD) said it submitted Abbreviated New Drug Application for a 120 milligram 12-hour pseudoephedrine tablet to the Food and Drug Administration. The company noted that this is the first application submitted by SCOLR based on its CDT platform.
Pseudoephedrine is an active ingredient in Allegra D, Sudafed PSE, Claritin D, Zyrtec D and other over-the-counter and prescription products as a decongestant.
Further, the company said it expects to complete the ibuprofen trial late this year. If approved, the company believes its ibuprofen product would be the first and only OTC 12-hour, extended-release ibuprofen product on the market in the U.S.
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