Perrigo Receives FDA Approval for Pseudoephedrine Extended-Release Tablets

Mar 04, 1999, 00:00 ET from Perrigo Company

    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
     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