Perrigo receives final approval from FDA for congestion relief tablets
Published on July 8, 2014 at 9:30 AM
Perrigo Company (NYSE: PRGO; TASE) today announced that it was the first to receive final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for ibuprofen and phenylephrine hydrochloride tablets, 200 mg/10 mg (over-the-counter), the store brand equivalent to Advil® Congestion Relief Tablets, 200 mg/10 mg. Perrigo expects to begin shipments of the product prior to the upcoming cough/cold/flu season.
Advil® Congestion Relief Tablets, 200 mg/10 mg, (ibuprofen & phenylephrine hydrochloride tablets, 200 mg/10 mg) is indicated for the relief of sinus pressure, nasal swelling and congestion, and headache. Estimated annual sales of the product are approximately $18 million.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This approval further strengthens our leading store brand position and highlights our commitment to bringing new affordable products to the market."