The US Food and Drug Administration (FDA) has granted final approval to Perrigo Company's 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 chief executive officer, 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."

From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri. The company is the world's largest manufacturer of OTC healthcare products for the store brand market and an industry leader in pharmaceutical technologies. Perrigo's mission is to offer uncompromised "Quality Affordable Healthcare Products" and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as more than 40 other key markets worldwide, including Canada, China and Latin America.