Mylan announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Zolmitriptan Tablets, the generic version of Impax Laboratories‘ Zomig. Zomig is indicated for the acute treatment of migraine with or without aura in adults.
Zolmitriptan, a selective 5-HT1B/1D receptor agonist, exerts agonist effects at the receptors on intracranial blood vessels (including the arterio-venous anastomoses) and sensory nerves of the trigeminal system. This is thought to result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release. Zolmitriptan also has moderate affinity for 5-HT1A receptors.
Zolmitriptan Tablets are available in 2.5mg and 5mg strengths. Mylan has begun shipping this product.
For more information call (800) RX-MYLAN or visit Mylan.com.