Table of Contents
PITTSBURGH — Mylan Inc. has received final approval from the Food and Drug Administration for zolmitriptan tablets, a treatment for migraine headaches.
The company said Wednesday that its zolmitriptan product, which has begun shipping, comes in dosages of 2.5 mg and 5 mg and is a generic version of Zomig Tablets from IPR Pharmaceuticals Inc.
Specifically, zolmitriptan tablets are indicated for the acute treatment of migraine with or without aura in adults, according to Mylan. They are intended to be used only where a clear diagnosis of migraine has been established and, if a patient doesn’t respond after the first dose, a health care provider should reconsider the diagnosis before readministering, the company said, adding that the product isn’t indicated for the prevention of migraine attacks or cluster headaches.
Zolmitriptan tablets (2.5 mg and 5 mg) had U.S. sales of about $152.8 million for the 12 months ended March 31, based on IMS Health data cited by Mylan.
