The Perrigo Company (NASDAQ: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market over-the-counter (OTC) tioconazole ointment and migraine formula tablets. These approvals were granted through the FDA's Abbreviated New Drug Application (ANDA) process.
The FDA determined that Perrigo's tioconazole ointment, 6.5%, is bioequivalent to Bristol-Myers Squibb's Vagistat®-1, marketed for the treatment of vaginal yeast infections. One-dose treatments are the fastest- growing products in the OTC feminine hygiene category with retail sales of approximately $60 million during the past 12 months. The FDA also concluded that Perrigo's migraine formula tablet containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg is bioequivalent to Bristol-Myers Squibb's Excedrin® Migraine marketed for the treatment of migraine pain. Excedrin® Migraine is the leading brand in the migraine relief product segment with retail sales of more than $70 million during the past 12 months.
Commenting on the approvals, Executive Vice President, Mark Olesnavage, stated, "We are pleased to receive these latest FDA approvals, which provide us with important additions to the feminine hygiene and analgesic product categories. The approvals enable Perrigo to continue to bring consumer value and innovation to the store brand marketplace. Tioconazole will be the first store brand product that offers consumers a one-dose treatment and our migraine formula tablet will be the first store brand product indicated for migraine pain relief."
Mr. Olesnavage also noted, "These new products are expected to begin shipping by our fourth quarter ending June 29, 2002. Also, with our migraine formula, we will receive 180 days of generic drug exclusivity following initial shipments."
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 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 see the "Cautionary Note Regarding Forward-Looking Statements" on pages 24-29 of the Company's Form 10-K for the year ended June 30, 2001 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.
Vagistat®-1 and Excedrin® Migraine are registered trademarks of Bristol-Myers Squibb Company.
SOURCE: Perrigo Company
Contact: Ernest J. Schenk, Manager, Investor Relations and Communication
of Perrigo Company, +1-616-673-9212, email: firstname.lastname@example.org
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