FDA Accepts Tris Pharma's ANDA with Paragraph IV Certification for a Generic Equivalent to Delsym

Tris Pharma, Inc., a drug delivery and specialty pharmaceutical company, confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 12-hour sustained release Dextromethorphan liquid suspension product prior to the expiration of a patent listed in the FDA's orange book for Reckitt Benckiser's Delsym product. Delsym, a leading OTC brand and the only FDA approved 12-hour liquid product for cough is different from most brands of cough medicine as the active ingredient is "time released" in liquid syrup. If approved, Tris Pharma's dextromethorphan polistirex suspension will be the generic version of Reckitt...

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