Migraine Drug Goes Generic

Generic version of zolmitriptan tentatively approved by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Drug company Glenmark Generics Inc, USA has announced that U.S. Food and Drug Administration officials have tentatively approved development of a generic migraine drug.

If given final approval, the company plans to produce 2.5 milligram and 5 milligram orally disintegrating tablets of zolmitriptan, the generic version of AstraZeneca’s Zomig-ZMT tablets.

"Ask a doctor about prescribed migraine treatments."

The drug is designed to relieve the symptoms of acute severe migraines, including nausea, vomiting and sensitivity to light and sound. Zolmitriptan helps shorten the length of time patients are affected by migraines and lessens headache severity while forcing constriction of blood vessels suspected of causing migraines.

The medication does not prevent future migraines.

Glenmark's tentative approval marks one of the first for a generic version of zolmitriptan. The introduction of new generics to the market usually benefits patients who can purchase drugs with the same chemical components at a cheaper price.

Even for those with prescription drug insurance, filling prescriptions for generics is usually substantially less expensive because co-pays tend to be lower.

Glenmark was granted FDA approval for its immediate release zolmitriptan tablets in September 2011. The company hopes to produce the active ingredients for both generic versions of the drug by May 2013 pending final FDA approval.

For the 12-month period that ended in March 2012, zolmitriptan immediate release tablets and orally disintegrating tablets achieved sales of $131 million and $31 million, respectively.

Glenmark is headquartered in Mumbai, India. While they supply pharmaceuticals to numerous different countries, they distribute at least 80 products in the U.S. at the current time.

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Review Date: 
May 17, 2012
Last Updated:
July 26, 2012