Home » Drug Information » FDA-Approved Drugs » 1998
Medical Areas: Neurology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Bristol-Myers Squibb
Approval Status: Approved January 1998
Treatment Area: Mild-to-moderate migraine
Bristol-Myers Squibb received approval of its Excedrin Migraine
for the treatment of pain associated with mild-to-moderate
migraine. It is the first over the counter drug to be approved for
this indication.
In trials involving about 1300 migraineurs, Excedrin Migraine
was found safe and effective in relieving migraine pain within
2-to-4 hours of dosing.
Excedrin Migraine contains 250 mg acetaminophen, 250 mg aspirin,
and 65 mg caffeine in each tablet. The ingredients are the same as
those in Excedrin Extra, which is already on the market, but the
product comes with instructions and warnings specific to
migraine.
