Regulatory Issues

Perrigo Gets FDA Nod On Treatments For Yeast Infections, Migraines

Published in Women's Health Weekly, January 10th, 2002

The Perrigo Company (PRGO) has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market over-the-counter tioconazole ointment and migraine formula tablets. These approvals were granted through the FDA's Abbreviated New Drug Application 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. 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.

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Source: Women's Health Weekly (2002-01-10)

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