The Perrigo Company (NASDAQ: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter (OTC) nicotine polacrilex gum and prescription ibuprofen oral suspension. Both approvals were granted through the Abbreviated New Drug Application (ANDA) process regulated by the FDA.
The FDA determined that Perrigo's nicotine polacrilex gum USP, 2 mg and 4 mg dosage, in regular, orange and mint flavors, to be bioequivalent to GlaxoSmithKline's Nicorette® gum, indicated as an aid to smoking cessation. Perrigo's nicotine gum will begin shipping in the first half of calendar 2005 and is expected to be one of three store brand competitors in the market.
The FDA also determined that Perrigo's ibuprofen oral suspension USP, 100 mg/5mL to be bioequivalent to McNeil's Motrin® Oral Suspension, indicated for pain relief and fever reduction. The ibuprofen suspension product represents the first generic prescription drug approval for Perrigo. It will begin shipping in the first half of calendar 2005 and will be the second ANDA approval for this drug.
Perrigo Company is the nation's largest manufacturer of over-the-counter (non-prescription) pharmaceutical and nutritional products sold by supermarket, drug, and mass merchandise chains under their own labels. The Company's products include over-the-counter pharmaceuticals such as analgesics, cough and cold remedies, gastrointestinal, and feminine hygiene products, and nutritional products, such as vitamins, nutritional supplements and nutritional drinks. Visit Perrigo on the Internet (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. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. Please see the "Cautionary Note Regarding Forward-Looking Statements" on pages 27 - 33 of the Company's Form 10-K for the year ended June 26, 2004 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 these forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. Unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Nicorette® is a registered trademark of GlaxoSmithKline Consumer Healthcare, L.P.
Motrin® is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals.
SOURCE: Perrigo Company
CONTACT: Ernest J. Schenk, Manager, Investor Relations and Communication
of Perrigo Company, +1-269-673-9212, or E-mail: eschenk@perrigo.com
Web site: http://www.perrigo.com/