The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Zolmitriptan tablets, 2.5mg and 5mg.
The generic equivalent of IPR Pharmaceuticals' Zomig tablets is indicated for the acute treatment of migraine with or without aura in adults.
Mylan commenced the product shipment.
The product is approved to be used only in case of establishment of a clear diagnosis of migraine but not for the prevention of migraine attacks or cluster headaches.
A healthcare provider should reconsider the diagnosis before re-administering in case a patient does not respond to first dose.
According to IMS Health, the US sales of Zolmitriptan Tablets were approximately $152.8m for the 12 months ending 31 March 2013.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-approves-mylan-zolmitriptan-anda-160513
