ALLEGAN, Mich., March 4 /PRNewswire/ -- The Perrigo Company (Nasdaq: PRGO) today announced that it has received approval from the Food and Drug Administration (FDA) to manufacture and market Pseudoephedrine Hydrochloride Extended-release Tablets, 120 mg. The approval is effective immediately and was granted through the Abbreviated New Drug Application (ANDA) process regulated by the FDA. The FDA concluded that Pseudoephedrine Hydrochloride Extended-release Tablets produced by Perrigo are safe and effective and bioequivalent to Sudafed(R) 12 Hour Extended-release Caplets, 120 mg. marketed by Warner- Lambert Company. Commenting on the approval, Mark Olesnavage, Perrigo President of Customer Business Development, stated, "We are very pleased to receive the FDA's approval for Pseudoephedrine Hydrochloride Extended-release Tablets. Although this product is only one of many over-the-counter pharmaceuticals that Perrigo markets as a store brand, it is significant because it is Perrigo's first ANDA approval utilizing an extended-release delivery form." Mr. Olesnavage also stated, "Perrigo is committed to sustaining a broad line of products for our customers' store brand programs and we continue to dedicate resources to the development and approval of new products. This approval demonstrates our commitment to the cough, cold and allergy product categories and we are now better able to help our retail customers meet the needs of consumers in these important categories." Perrigo Company is the nation's largest manufacturer of over-the-counter (non-prescription) pharmaceutical, nutritional and personal care products for the store brand market. Store brand products are sold by national and regional supermarket, drugstore and mass merchandise chains under their own labels and compete with nationally advertised brands. The Company's products include over-the-counter pharmaceuticals (such as analgesics, cough and cold remedies, antacids, laxatives, suppositories, and feminine hygiene products), nutritional products (such as vitamins, nutritional supplements and nutritional drinks) and personal care products (such as toothpaste and mouthwash, hair care products, "wets", baby care products, and skin care and sun care products). On June 29, 1998, the Company announced its intention to divest the personal care products category. Visit Perrigo on the Internet at http://www.perrigo.com. Note: Certain statements in this press release are forward looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and are subject to the safe harbor created thereby. Please refer to pages 27-31 of the Company's Form 10-K for the year ended June 30, 1998 for a discussion of certain important factors that relate to forward looking statements contained in this press release. Although the Company believes that the expectations reflected in any such forward looking statements are reasonable, it can give no assurance that such expectations will prove to be correct.
SOURCE Perrigo Company