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news.Perrigo Company has announced FDA approval of Tris Pharma's abbreviated new drug application (ANDA) for Dextromethorphan Polistirex extended-release oral suspension.
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Perrigo is the exclusive marketer and distributor of the product for the store brand over-the-counter (OTC) market in the US.
Perrigo expects to begin shipment of the product during its first fiscal quarter of 2013.
Perrigo chairman and CEO Joseph Papa said, "We are pleased to add this important new product to our retail and wholesale customers’ store brand product portfolios when we begin shipments to them for the upcoming cough/cold/flu season."
Dextromethorphan Polistirex extended-release oral suspension is the store brand equivalent to Reckitt Benckiser’s Delsym suspension indicated for the treatment of cough due to minor throat and bronchial irritation.