Mylan announced it has received final approval from the FDA for its Abbreviated New Drug Applications (ANDA) for Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets (ODT), the generic versions of Merck‘s Maxalt and Maxalt-MLT. Maxalt and Maxalt-MLT are selective 5-HT1B/1D receptor agonists indicated for the acute treatment of migraine with or without aura.
Maxalt is presumed to exert its therapeutic effects in the treatment of migraine headache by binding to the receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.
Both the Rizatriptan Benzoate Tablets and the orally disintegrating tablets are available in 5mg and 10mg dosage strengths.
For more information call (800) RX-MYLAN or visit www.mylan.com.