The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals' abbreviated new drug applications (ANDA) for the generic equivalents to Merck's Maxalt MLT tablets and Maxalt tablets.
Rizatriptan Benzoate orally disintegrating tablets, 5mg (base) and 10mg (base), and Rizatriptan Benzoate tablets, 5mg (base) and 10mg (base) are the generic versions of Maxalt MLT Tablets and Maxalt Tablets respectively.
The generic products are indicated as migraine therapy for adults with or without aura.
Mylan CEO Heather Bresch said, "Mylan's immediate launch of the first generic Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg (base) and 10 mg (base), and the company's simultaneous launch of Rizatriptan Benzoate Tablets, 5 mg (base) and 10 mg (base), further demonstrates our commitment to continue expanding access to high quality medicines for patients who need them in the U.S. and around the world."
The regulatory body has granted marketing exclusivity for 180 days for Rizatriptan Benzoate Orally Disintegrating Tablets, 5mg (base) and 10mg (base).
The company has commenced the shipment of the orally disintegrating and immediate-release versions of the product.
