MONMOUTH JUNCTION, N.J. — Tris Pharma on Thursday announced that the Food and Drug Administration has approved its generic equivalent to Reckitt Benckiser's Delsym, an extended-release oral liquid suspension containing dextromethorphan.
Delsym was approved in 1982 and there has never been any generic alternative approved until now, the company noted. "This is the third extended-release liquid product approved by the FDA based on our patented technology, and speaks to Tris' capabilities to develop and commercialize difficult products," Tris Pharma president and CEO Ketan Mehta said.
Perrigo will be Tris' exclusive partner in distributing this product as a store-brand alternative to Delsym for the coming cough-cold-flu season. Annual sales across the entire Delsym brand are estimated at more than $100 million, Tris Pharma said.