The US Food and Drug Administration (FDA) has granted final approval to Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for zolmitriptan tablets, 2.5 mg and 5 mg. This product is the generic version of IPR Pharmaceuticals Inc.'s Zomig tablets and is indicated for the acute treatment of migraine with or without aura in adults.
Zolmitriptan tablets are for use only where a clear diagnosis of migraine has been established. If a patient does not respond after the first dose, a healthcare provider should reconsider the diagnosis before re-administering. The product is not indicated for the prevention of migraine attacks or cluster headaches.
Zolmitriptan tablets, 2.5 mg and 5 mg, had US sales of approximately $152.8 million for the 12 months ending March 31, 2013, according to IMS Health. Mylan has begun shipping this product.
Currently, Mylan has 178 ANDAs pending FDA approval representing $83.1 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.4 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.
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